JP2016512753A - Prosthetic heart valve device, prosthetic mitral valve, and related systems and methods - Google Patents

Abstract

Disclosed herein are prosthetic heart valve devices for percutaneous replacement of natural heart valves, and related systems and methods. A prosthetic heart valve device configured in accordance with certain embodiments of the present technology is adapted to engage tissue on or near an annulus of a natural heart valve and to deform into a non-circular shape to conform to the tissue. It may comprise an anchoring member having an upstream portion configured. The device can also include a mechanically isolated valve support coupled to the anchor member and configured to support the prosthetic valve. The device can further include an atrial dilator member that extends radially outward from an upstream portion of the anchoring member and is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the expansion member may be deformed while the valve support remains sufficiently stable. [Selection] Figure 86B

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application includes US Provisional Patent Application No. 61 / 605,699, the title of the invention “SYSTEM FOR MITRAL VALVE REPLACEMENT” (filing date March 1, 2012), and US Provisional Patent Application No. 61/549. No. 044, the title of the invention “CONFORMABLE SYSTEM FOR MITRAL VALVE REPLACEMENT” (filed on October 19, 2011), PCT / US2012 / 61219, the title of the invention “PROSTHETIC HEART VALVE DEVICES, PRICE, PRICE MITRAL VALVES AND ASSOCIATED SYSTEMS AND METHODS "(Filing Date 19 October 2012) No. 3 / 842,785, US Patent Application No. 13/946, a partial continuation application of the title “PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATES SYSTEMS AND METHODS” (filing date March 15, 2013) No. 552, the title of the invention “PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATES SYSTEMS AND METHODS” (filing date 19 July 2013), the disclosure of which is entirely incorporated by reference Incorporated herein. This application also claims priority to US Provisional Patent Application No. 61 / 898,345, the title of the invention “PROSTHETIC HEART VALVE DEVICE” (filed Oct. 31, 2013), the disclosure of which is hereby incorporated by reference. The entirety is incorporated herein. The present application includes (1) International Patent Application No. PCT / US2012 / 043636, title of invention “PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS” (filing date June 21, 2012), (2) US Provisional Patent Application No. 61 / 549,037, the title of the invention “SYSTEM FOR MITRAL VALVE REPLACEEMENT” (filing date October 19, 2011), and (3) International Patent Application No. PCT / US2012 / 61215, the title of the invention “DEVICES, SYSTEMS” The entire content of the subject of "AND METHODS FOR HEART VALVE REPLACEMENT" (filing date October 19, 2012) is incorporated by reference.

  The present technology relates generally to prosthetic heart valve devices. In particular, some embodiments are directed to prosthetic mitral valves and devices for percutaneous repair and / or replacement of natural mitral valves, and related systems and methods.

  Symptoms that affect the proper functioning of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is a cardiac disorder in which the mitral leaflets cannot join in parallel at peak contraction pressure, resulting in abnormal leakage of blood from the left ventricle into the left atrium. There are several structural factors that can affect the proper closure of the mitral leaflet. For example, many patients suffering from heart disease experience myocardial dilation resulting in an enlarged mitral annulus. The expansion of the mitral annulus makes it difficult for the leaflets to join during systole. The extension or laceration of the chord, the tendon that connects the papillary muscle to the underside of the mitral leaflet, can also affect the proper closure of the mitral annulus. A torn chord can cause the leaflet to escape into the left atrium, for example, due to insufficient tension on the leaflet. Abnormal reflux can also occur when papillary muscle function is impaired, for example, by ischemia. When the left ventricle contracts during systole, the affected papillary muscle does not contract sufficiently to achieve proper closure.

  When the mitral valve prolapse, or the mitral leaflet abnormally protrudes into the left atrium, it can cause irregular behavior of the mitral valve and can also lead to mitral regurgitation. The normal function of the mitral valve can also be affected by mitral stenosis or mitral valve aperture narrowing, which causes impaired filling of the left ventricle during diastole.

  Typically, treatment of mitral regurgitation has involved the application of diuretics and / or vasodilators to reduce the amount of blood that flows back into the left atrium. Other procedures have involved surgical approaches (thoracotomy and endovascular) for either valve repair or replacement. For example, typical repair approaches have involved tightening or excising the expanded annulus portion.

  Tightening the annulus has generally been accomplished by implantation of an annulus or annulus annulus that is secured to the annulus or surrounding tissue. Other repair procedures have also involved suturing or tightening the leaflets, partially in parallel with each other.

  Alternatively, more invasive procedures have involved replacement of the entire valve itself, where a mechanical valve or biological tissue is implanted in the heart instead of the mitral valve. These invasive procedures are conventionally performed through massive thoracotomy and are therefore very painful, have significant morbidity and require a long recovery period.

  However, in many repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can pose additional problems for the patient. Also, many of the repair procedures are highly dependent on the skills of the cardiac surgeon, where poor or improperly placed sutures can affect the success of the procedure.

  In recent years, minimally invasive approaches to aortic valve replacement have been developed. Examples of preassembled percutaneous prosthetic valves can be found in, for example, Medtronic / Corevalve Inc. CoreValve Reving (R) System from (Irvine, CA, USA), and Edwards-Sapien (R) Valve from Edwards Lifesciences (Irvine, CA, USA). Both valve systems include an expandable frame that houses a trilobal biological valve. The frame is enlarged to fit a substantially symmetric and circular rigid aortic annulus. This is suitable for supporting a trilobal prosthetic valve (which requires such symmetry for proper jointing of the prosthetic valve leaflet) in the expandable frame of the delivery configuration, in the aortic annulus Gives a symmetrical circular shape. Thus, the aortic valve anatomy is suitable for an expandable frame that houses a replacement valve, since the aortic valve anatomy is substantially uniform, symmetrical, and extremely rigid.

  Mitral valve replacement presents unique anatomical obstacles compared to aortic valve replacement, making percutaneous mitral valve replacement significantly more difficult than aortic valve replacement. First, unlike the relatively symmetric and uniform aortic valve, the mitral annulus is a non-circular D-shaped or renal, often with a non-planar heel-like geometry that lacks symmetry. It has such a shape. Such unpredictability makes it difficult to design an artificial mitral valve that has the ability to match the mitral annulus. The lack of a snug fit between the prosthesis and the natural leaflets and / or annulus can leave gaps between them and cause backflow of blood through these gaps. Cylindrical prosthetic valve placement, for example, can leave gaps in the commissure areas of the natural valve, potentially leading to perivalvular leakage in these areas.

  Current prosthetic valves developed for percutaneous aortic valve replacement are inappropriate for adaptation to mitral valves. First, many of the devices require direct structural connections between device structures that contact the annulus and / or leaflets and the device structure that supports the prosthetic valve. In some devices, the same stent column that supports the prosthetic valve also contacts the annulus or other surrounding tissue, and as the heart contracts during each cardiac cycle, much of the distortion force exerted by the tissue and blood is increased. Communicate directly to the device. Most heart replacement devices further require a substantially symmetrical cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets for many years of life. Use a valve. When these devices are subjected to movement and force from the annulus and other surrounding tissues, the prosthesis can be compressed and / or distorted, causing the prosthetic valve leaflets to malfunction. Also, the typical affected mitral annulus is much larger than any available prosthetic valve. As the size of the valve increases, the force on the leaflets increases dramatically, so simply increasing the size of the prosthetic aorta to the size of the expanded mitral annulus is dramatically thicker and longer. Requires a cusp and may not be feasible.

  In addition to its irregular and unpredictable shape that changes size during each beat, the mitral annulus lacks a significant amount of radial support from the surrounding tissue. The aortic valve is completely surrounded by fiber elastic tissue, which helps to secure the prosthetic valve, for example, by providing natural structural support. On the other hand, the mitral valve is connected only by muscle tissue on the outer wall. The inner wall of the mitral valve is joined by a thin vessel wall that separates the mitral annulus from the lower part of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as the force imparted by expanding the stent prosthesis, can lead to collapse of the lower part of the aortic tract, with potentially fatal consequences.

  The left ventricular chord can also present an obstacle in deploying the prosthetic mitral valve. This is unique to mitral valves because the aortic valve anatomy does not contain chordae. A chordal cord like a maze in the left ventricle makes it more difficult to navigate and position the deployment catheter in mitral valve replacement and repair. The deployment and positioning of a prosthetic valve or anchoring device on the ventricular side of a natural mitral valve is further complicated by the presence of chordae.

  Although the tricuspid valve on the right side of the heart usually has three leaflets, it poses a similar challenge for minimally invasive treatment, like the mitral valve. Therefore, there is also a need for a better prosthesis for treating tricuspid valve disease.

  Given the difficulties associated with current procedures, there remains a need for simple and effective minimally invasive devices and methods for treating dysfunctional heart valves.

  Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure. Further, the components may be shown as transparent in certain figures for clarity of illustration only, and not to show that the illustrated components are necessarily transparent.

1 is a schematic illustration of a mammalian heart having a natural valve structure suitable for replacement with various prosthetic heart valve devices, according to embodiments of the present technology. FIG. 1 is a schematic illustration of a mammalian heart having a natural valve structure suitable for replacement with various prosthetic heart valve devices, according to embodiments of the present technology. FIG. FIG. 6 is a schematic cross-sectional side view of a natural mitral valve showing an annulus and leaflets. Suitable for combination with various prosthetic heart valve devices according to embodiments of the present technology, i) prolapse valve leaflets within the mitral valve, or ii) mitral in the left ventricle of the heart with impaired papillary muscle FIG. 6 is a schematic view of the left ventricle of the heart with either one of the valve regurgitation. 1 is a schematic view of a heart of a patient suffering from cardiomyopathy, suitable for combination with various prosthetic heart valve devices, according to embodiments of the present technology. FIG. FIG. 5 is a schematic illustration of a natural mitral valve of the heart showing normal closure of the natural mitral leaflet. 1 is a schematic illustration of a natural mitral valve of a heart showing an abnormal closure of a natural mitral valve leaflet in an expanded heart, suitable for combination with various prosthetic heart valve devices, according to embodiments of the present technology. FIG. 1 is a schematic illustration of a mitral valve of a heart showing the dimensions of an annulus suitable for combination with various prosthetic heart valve devices, according to embodiments of the present technology. FIG. 1 is a schematic cross-sectional view of a heart showing an antegrade approach from a venous vasculature to a natural mitral valve according to various embodiments of the present technology. FIG. 1 is a schematic cross-sectional view of a heart showing access through an atrial septum (IAS) maintained by placement of a guide catheter on a guidewire, according to various embodiments of the present technology. FIG. 2 is a schematic cross-sectional view of the heart showing a retrograde approach to a natural mitral valve through the aortic valve and the arterial vasculature, according to various embodiments of the present technology. FIG. 2 is a schematic cross-sectional view of the heart showing a retrograde approach to a natural mitral valve through the aortic valve and the arterial vasculature, according to various embodiments of the present technology. FIG. 1 is a schematic cross-sectional view of a heart illustrating an approach to a natural mitral valve using transapical perforations according to various embodiments of the present technology. FIG. FIG. 3 shows an isometric view of a prosthetic heart valve device, according to an embodiment of the present technology. FIG. 10D illustrates a cutaway view of the heart showing the prosthetic treatment device of FIG. 10C-10F are a side view, perspective cutaway view, top view, and bottom view, respectively, of a prosthetic heart valve device, according to an embodiment of the present technology. 10C-10F are a side view, perspective cutaway view, top view, and bottom view, respectively, of a prosthetic heart valve device, according to an embodiment of the present technology. 10C-10F are a side view, perspective cutaway view, top view, and bottom view, respectively, of a prosthetic heart valve device, according to an embodiment of the present technology. 10C-10F are a side view, perspective cutaway view, top view, and bottom view, respectively, of a prosthetic heart valve device, according to an embodiment of the present technology. FIG. 3 is a side view of an enlarged valve support in accordance with an embodiment of the present technology. FIG. 6 is an isometric view of an additional embodiment of a valve support with a prosthetic valve mounted therein according to the present technology. FIG. 6 is an isometric view of an additional embodiment of a valve support with a prosthetic valve mounted therein according to the present technology. FIG. 6 is an isometric view of an additional embodiment of a valve support with a prosthetic valve mounted therein according to the present technology. 1 is a side view of a valve support having a support band and a prosthetic valve mounted therein according to the present technology. FIG. 1 is a side view of a valve support having a support band and a prosthetic valve mounted therein according to the present technology. FIG. 1 is a side view of a valve support having a support band and a prosthetic valve mounted therein according to the present technology. FIG. FIG. 6 shows an isometric view of a prosthetic heart valve device according to another embodiment of the present technology. 12A-12C are side views of various longitudinal ribs that flex in response to distortion forces, according to further embodiments of the present technology. FIG. 13A is a schematic cross-sectional view of a prosthetic heart valve device according to another embodiment of the present technology. 13B-13F are partial side views of a prosthetic heart valve device illustrating various longitudinal rib configurations, according to additional embodiments of the present technology. FIG. 6 is a schematic top view of a natural mitral valve illustrating the major and minor axes. 14B to 14C are schematic top views of a securing member in an expanded configuration and a deployed configuration, respectively, according to embodiments of the present technology. 14B to 14C are schematic top views of a securing member in an expanded configuration and a deployed configuration, respectively, according to embodiments of the present technology. 2 is an isometric view of a prosthetic heart valve device illustrated in a deployed configuration, according to additional embodiments of the present technology. FIG. FIG. 7 is a top view of a prosthetic heart valve device illustrated in an expanded configuration, according to a further embodiment of the present technology. 16B-16C are a first side view and a second side view, respectively, of the prosthetic heart valve device of FIG. 16A. 16B-16C are a first side view and a second side view, respectively, of the prosthetic heart valve device of FIG. 16A. 6 is a side view of a prosthetic heart valve device showing the longitudinal axis of a fixation member offset from the longitudinal axis of the valve support by a tilt angle, according to another embodiment of the present technology. FIG. FIG. 17 is a schematic top view of a natural mitral valve in the heart as viewed from the left atrium, illustrating the prosthetic treatment device of FIGS. 16A-16C implanted in a natural mitral valve, according to an embodiment of the present technology. 17A-17C are a schematic top view and first and second side views of the prosthetic heart valve device of FIG. 16A showing the dimensions and taper angles of the various sides of the device, according to embodiments of the present technology. 6 is an isometric view of a securing member illustrated in an enlarged configuration, according to yet another embodiment of the present technology. FIG. 19A-19C are isometric, side, and top views, respectively, of a prosthetic heart valve device having a sealing member, according to a further embodiment of the present technology. 1 is an isometric view of a prosthetic heart valve device without a sealing member, according to an embodiment of the present technology. FIG. 20B-20E are isometric views of a prosthetic heart valve device having a sealing member, according to additional embodiments of the present technology. 20B-20E are isometric views of a prosthetic heart valve device having a sealing member, according to additional embodiments of the present technology. 20B-20E are isometric views of a prosthetic heart valve device having a sealing member, according to additional embodiments of the present technology. 20B-20E are isometric views of a prosthetic heart valve device having a sealing member, according to additional embodiments of the present technology. 21A-21B are cross-sectional side and isometric views of a prosthetic heart valve device having a tubular valve support member, according to a further embodiment of the present technology. 21C-21F are partial cross-sectional side and isometric views of a prosthetic heart valve device having a tubular valve support member, according to another embodiment of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. FIG. 40B is a side view of a post within the prosthetic heart valve device of FIG. 40G. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 22A-22G and 22I-22K are enlarged side views of various mechanisms for coupling the valve support to the anchoring member, according to additional embodiments of the present technology. 23A-23B are enlarged side views of additional mechanisms for coupling the anchoring member to the valve support member, according to a further embodiment of the present technology. FIG. 6 is a perspective view of an integral connection between a valve support and a securing member, according to additional embodiments of the present technology. Figures 24B-24D are enlarged views of additional embodiments of an integral connection between the valve support and the anchoring member according to the present technology. Figures 24B-24D are enlarged views of additional embodiments of an integral connection between the valve support and the anchoring member according to the present technology. Figures 24B-24D are enlarged views of additional embodiments of an integral connection between the valve support and the anchoring member according to the present technology. 1 is a partial cross-sectional view of a prosthetic heart valve device having an anchoring member and a valve support, according to an embodiment of the present technology. FIG. FIG. 25B is an enlarged view of the designation box shown in FIG. 25A. 26A-26D are schematic cross-sectional views of a prosthetic heart valve device having an atrial retainer and implanted in a natural mitral valve, according to various embodiments of the present technology. FIG. 6 is a side view of a securing member having a vertical portion at an upstream end for engaging an annulus according to another embodiment of the present technology. 1 is a side view of an expanded configuration prosthetic heart valve device having a plurality of stabilizing elements, in accordance with an embodiment of the present technology. FIG. 1 is an enlarged schematic side view of a prosthetic heart valve device having an extended arm, according to an embodiment of the present technology. FIG. 30A-30C are enlarged partial side views of a prosthetic heart valve device having arms connected to the device at various angles to the longitudinal axis of the device, according to further embodiments of the present technology. 31A-31C are enlarged partial side views of a prosthetic heart valve device having various lengths of arms coupled to the device, according to additional embodiments of the present technology. 32A, 32B, 32C, and 32D are cross-sectional views of the heart with an implanted prosthetic heart valve device having an arm disposed on the inwardly facing surface of the leaflet, according to various embodiments of the present technology. is there. 32A-1, 32B-1, 32C-1, and 32D-1 are respectively the inwardly facing surfaces of the leaflets as shown in FIGS. 32A, 32B, 32C, and 32D, according to various embodiments of the present technology. It is an enlarged view of the arm engaged with. 33A-33C are schematic diagrams illustrating various embodiments of tissue engaging elements for use with a prosthetic heart valve device in accordance with the present technology. FIGS. 34A, 34B, and 34C illustrate a heart with an implanted prosthetic heart valve device having an arm with a tissue engaging element disposed on an inwardly facing surface of a leaflet, according to various embodiments of the present technology. FIG. 34A-1, 34B-1, and 34C-1 are views of an arm that engages the inwardly facing surface of a leaflet as shown in FIGS. 34A, 34B, and 34C, respectively, according to various embodiments of the present technology. It is an enlarged view. FIGS. 35A-35C are prosthetic heart valve devices shown embedded in a mitral valve (shown in cross-section) according to a further embodiment of the present technology, engaging the outward surface of a natural leaflet FIG. 6 is a side view of a device having an arm for FIGS. 35A-35C are prosthetic heart valve devices shown embedded in a mitral valve (shown in cross-section) according to a further embodiment of the present technology, engaging the outward surface of a natural leaflet FIG. 6 is a side view of a device having an arm for FIGS. 35A-35C are prosthetic heart valve devices shown embedded in a mitral valve (shown in cross-section) according to a further embodiment of the present technology, engaging the outward surface of a natural leaflet FIG. 6 is a side view of a device having an arm for FIG. 35B is an enlarged view of an arm engaging an inwardly facing surface of a leaflet as shown in FIG. 35C, according to various embodiments of the present technology. An artificial heart valve device, shown embedded in a mitral valve (shown in cross section), according to an additional embodiment of the present technology, the arm for engaging an outward surface of a natural leaflet; And FIG. 10 is a side view of the device with arms for engaging the inwardly facing surface of the natural leaflet. FIG. 36B is an enlarged view of an arm that engages the inward and outward surfaces of a leaflet as shown in FIG. 36A. 37A-37D are enlarged side views of additional embodiments of an arm suitable for use with a prosthetic heart valve device in accordance with the present technology. 3 is a side view of a prosthetic heart valve device having a plurality of non-interconnected arms, according to a further embodiment of the present technology. FIG. 3 is a side view of a prosthetic heart valve device having a plurality of circumferentially connected arms, according to a further embodiment of the present technology. FIG. 39A-39D are schematic top views of arm position patterns, according to additional embodiments of the present technology. 40A-40D are side views of a prosthetic heart valve device having tissue engaging elements on various structures of the device, according to additional embodiments of the present technology. 40A-40D are side views of a prosthetic heart valve device having tissue engaging elements on various structures of the device, according to additional embodiments of the present technology. 40A-40D are side views of a prosthetic heart valve device having tissue engaging elements on various structures of the device, according to additional embodiments of the present technology. 40A-40D are side views of a prosthetic heart valve device having tissue engaging elements on various structures of the device, according to additional embodiments of the present technology. 40E-40G are enlarged side views of tissue engaging elements suitable for use with a prosthetic heart valve device, according to other embodiments of the present technology. 40E-40G are enlarged side views of tissue engaging elements suitable for use with a prosthetic heart valve device, according to other embodiments of the present technology. 40E-40G are enlarged side views of tissue engaging elements suitable for use with a prosthetic heart valve device, according to other embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. FIG. 3 is an isometric view of a prosthetic heart valve device having a plurality of annulus engagement elements according to further embodiments of the present technology. 42A-42B are cross-sectional side and enlarged views of a prosthetic heart valve device having a tissue engaging element deployable from a plurality of tubular ribs, according to another embodiment of the present technology. 43A-43B are isometric and enlarged detail views of a prosthetic heart valve device having a sealing member configured with a tissue engaging element, according to another embodiment of the present technology. 44A-44F are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, according to additional embodiments of the present technology. 1 is an isometric view of a prosthetic heart valve device having a plurality of tethers between an anchoring member 110 and a valve support 120, according to an embodiment of the present technology. FIG. 6 is an isometric view of a prosthetic heart valve device having multiple septums between an anchoring member 110 and a valve support 120, according to another embodiment of the present technology. 1 is a side cutaway view of a delivery system, according to an embodiment of the technology. FIG. 2 is an enlarged cross-sectional view of a distal end of a delivery system, according to an embodiment of the present technology. FIG. 46B is an enlarged partial side view of a valve support configured for use with the delivery system of FIG. 46B, according to an embodiment of the present technology. FIG. 46B is an enlarged partial side view of a valve support configured for use with the delivery system of FIG. 46B, according to an embodiment of the present technology. 47A-47D are cross-sectional views of the heart showing an antegrade or transseptal approach to a mitral valve according to an embodiment of the present technology. 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach, according to another embodiment of the present technology. 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach, according to another embodiment of the present technology. 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach, according to another embodiment of the present technology. 49A-49B are cross-sectional views of the heart showing a retrograde approach to the mitral valve via the aorta and left ventricle, according to a further embodiment of the present technology. 50A-50B are cross-sectional views of the heart illustrating a further embodiment of a method of implanting a prosthetic heart valve device using a transapical approach, according to aspects of the present technique. 51A-51B are partial side views of a delivery system in which a prosthetic heart valve device is mounted on an expandable balloon of a delivery catheter, according to another embodiment of the present technology. 1 is a cross-sectional view of a heart illustrating a method for delivering a prosthetic heart valve device having a valve support movably coupled to a fixation member, according to a further embodiment of the present technology. FIG. 1 is a cross-sectional view of a heart illustrating a method for delivering a prosthetic heart valve device having a valve support movably coupled to a fixation member, according to a further embodiment of the present technology. FIG. 1 is a cross-sectional view of a heart illustrating a method for delivering a prosthetic heart valve device having a valve support movably coupled to a fixation member, according to a further embodiment of the present technology. FIG. 1 is a cross-sectional view of a heart illustrating a method for delivering a prosthetic heart valve device having a valve support movably coupled to a fixation member, according to a further embodiment of the present technology. FIG. 53A-53D are partial side views illustrating various mechanisms for movably coupling a valve support to a securing member, according to additional embodiments of the present technology. FIG. 53E is a partial top view of the device of FIG. 53D. FIG. 53F is a side view of an alternative mechanism for slidably connecting a valve support and a securing member according to another embodiment of the present technology. 53G-53H are schematic side views of a prosthetic heart valve device showing yet another mechanism for coupling a valve support to an anchoring member, according to a further embodiment of the present technology. FIG. 7 is a cross-sectional side view of another embodiment of a delivery system for a prosthetic heart valve device according to another aspect of the present technology. FIG. 54B is a partial cross-sectional side view of the distal portion of the delivery system of FIG. 54A. 55A-55C are perspective views of the delivery system of FIG. 46 illustrating the steps of delivering the prosthetic treatment device of the present invention. FIG. 6 is a side cross-sectional view of a further embodiment of a delivery system for an artificial therapy device of the present invention. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 57B is a schematic cross-sectional view of the prosthetic heart valve device of FIG. 57A implanted in a natural mitral valve, according to an embodiment of the present technology. FIG. 6 is a cross-sectional view of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach according to another embodiment of the present technology. FIG. 6 is a cross-sectional view of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach according to another embodiment of the present technology. FIG. 6 is a cross-sectional view of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach according to another embodiment of the present technology. FIG. 6 is a cross-sectional view of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach according to another embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is an isometric view of an artificial therapy device according to an additional embodiment of the present technology. FIG. 6 is a schematic cross-sectional view of a prosthetic heart valve device implanted in a natural mitral valve according to another embodiment of the present technology. 60A-60B are cross-sectional side views of the distal end of a delivery catheter for delivering the prosthetic heart valve device of FIG. 59C to a native mitral valve in the heart, according to another embodiment of the present technology. 6 is a side view of a prosthetic heart valve device having first and second anchoring members for engaging mitral valve supra-annular and sub-annular tissue, respectively, according to yet another embodiment of the present technology. FIG. . 62A-62C are partial cross-sectional side views of the distal end of a delivery system showing delivery of the prosthetic heart valve device of FIG. 61 in a mitral valve according to another embodiment of the present technology. FIG. 6 is an isometric side view of a prosthetic heart valve device having an anchoring member with an annulus engagement ring and an annulus engagement ring, according to a further embodiment of the present technology. 64A-64D are side views of the prosthetic heart valve device of FIG. 63, illustrating an embodiment of a method for deploying the device in the mitral annulus, according to aspects of the present technique. FIG. 6 is a cross-sectional view of a prosthetic heart valve device having an inflatable anchor member shown embedded in a natural mitral valve of the heart, according to another embodiment of the present disclosure. FIG. 65B is a partial cross-sectional side view of the distal end of a delivery system suitable for delivery of the prosthetic heart valve device of FIG. 65A, according to another embodiment of the present technology. FIG. 4 is a cross-sectional view of a prosthetic heart valve device having a fillable chamber, according to additional embodiments of the present technology. FIG. 4 is a cross-sectional view of a prosthetic heart valve device having a fillable chamber, according to additional embodiments of the present technology. FIG. 4 is a cross-sectional view of a prosthetic heart valve device having a fillable chamber, according to additional embodiments of the present technology. FIG. 4 is a cross-sectional view of a prosthetic heart valve device having a fillable chamber, according to additional embodiments of the present technology. FIG. 6 is an isometric view of an additional embodiment of a prosthetic heart valve device in accordance with aspects of the present technology. FIG. 6 is an isometric view of an additional embodiment of a prosthetic heart valve device in accordance with aspects of the present technology. 68A-68B are side views of a prosthetic heart valve device having a locating element, according to additional embodiments of the present technology. 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. 6 is a cross-sectional side view of another prosthetic heart valve device configured in accordance with an embodiment of the present technology. FIG. FIG. 9 is a cross-sectional side view of yet another prosthetic heart valve device configured in accordance with an embodiment of the present technology. FIG. 6 is an isometric view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. 73 is a side view of the prosthetic heart valve device of FIG. 72. FIG. 73 is a bottom view of the prosthetic heart valve device of FIG. 72. 3 is a side view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. FIG. 76 is a bottom view of the prosthetic heart valve device of FIG. 75. 3 is a side view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. FIG. 6 is an isometric view of a prosthetic heart valve device according to another embodiment of the present technology. 79A and 79B are partial anatomical cross-sections and side views of the heart (H) of an embodiment of a prosthetic heart valve device implanted according to the method of the present technology. 79A and 79B are partial anatomical cross-sections and side views of the heart (H) of an embodiment of a prosthetic heart valve device implanted according to the method of the present technology. 2 is a partial anatomical section of a heart (H) showing the placement of a prosthetic heart valve device, according to an embodiment of the present technology. 2 is a partial anatomical section of a heart (H) showing the placement of a prosthetic heart valve device, according to an embodiment of the present technology. 80A-80Q are schematic cross-sectional views of some embodiments of a prosthetic heart valve device according to the present technology. 80A-80Q are schematic cross-sectional views of some embodiments of a prosthetic heart valve device according to the present technology. 80A-80Q are schematic cross-sectional views of some embodiments of a prosthetic heart valve device according to the present technology. 80A-80Q are schematic cross-sectional views of some embodiments of a prosthetic heart valve device according to the present technology. 80A-80Q are schematic cross-sectional views of some embodiments of a prosthetic heart valve device according to the present technology. 3 is a cross-sectional view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. FIG. 81B is a top view of the prosthetic heart valve device of FIG. 81A. FIG. 6 is an isometric view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. 82B is a cross-sectional view of the prosthetic heart valve device of FIG. 82A taken along line 20B-20B. FIG. 3 is a schematic cross-sectional view of a prosthetic heart valve device according to another embodiment of the present technology. 84A-84C are schematic cross-sectional views of the operation of a prosthetic heart valve device according to the present technology. 85A-85C are schematic side views of a portion of a prosthetic heart valve device according to the present technology. 86A-86B are side and isometric views of a prosthetic heart valve device according to another embodiment of the present technology. 86A-86B are side and isometric views of a prosthetic heart valve device according to another embodiment of the present technology. 87A-87B are side and top views of another prosthetic heart valve device, according to another embodiment of the present technology. 88A-88C are cross-sectional views of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach, according to another embodiment of the present technology. 88A-88C are cross-sectional views of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach, according to another embodiment of the present technology. 88A-88C are cross-sectional views of the heart illustrating a method for delivering a prosthetic heart valve device to a natural mitral valve in the heart using a transapical approach, according to another embodiment of the present technology. 89A and 89B are schematic top views of a natural mitral valve in the heart as viewed from the left atrium, showing the prosthetic treatment device of FIGS. 86A and 86B implanted in the natural mitral valve according to the present technology. 90A-90F are schematic diagrams illustrating how the prosthetic heart valve device of FIGS. 86A and 86B mechanically isolates the valve support, according to additional embodiments of the present technology. 90A-90F are schematic diagrams illustrating how the prosthetic heart valve device of FIGS. 86A and 86B mechanically isolates the valve support, according to additional embodiments of the present technology. FIG. 6 is an isometric view of a prosthetic heart valve device according to yet another embodiment of the present technology. FIG. 91B is a cross-sectional view of the device shown in FIG. 91A. FIG. 6 is a top view of a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 6 is a top view of a prosthetic heart valve device according to another embodiment of the present technology. FIG. 9 is a top view of a prosthetic heart valve device according to yet another embodiment of the present technology. 95A and 95B are top views of a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 6 is an isometric view of a prosthetic heart valve device according to yet another embodiment of the present technology. 96B and 96C are enlarged schematic views of portions of the prosthetic heart valve device of FIG. 96A. 96B and 96C are enlarged schematic views of portions of the prosthetic heart valve device of FIG. 96A. 97A and 97B are top and isometric views of a prosthetic heart valve device, according to an embodiment of the present technology. 98A-98C are top views of a prosthetic heart valve device according to a further embodiment of the present technology. 98A-98C are top views of a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 9 is a top view of a prosthetic heart valve device according to yet another embodiment of the present technology. FIG. 6 is a side view illustrating a method of delivering a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 100B is a top view of the prosthetic heart valve device of FIG. 100A. FIG. 6 is a top view of a prosthetic heart valve device according to another embodiment of the present technology. 1 is an isometric view of a prosthetic heart valve device according to an embodiment of the present technology. FIG. 2 is an isometric view of a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 104A and 104B are side views of a prosthetic heart valve device according to a further embodiment of the present technology. FIG. 6 is an isometric view of a prosthetic heart valve device according to yet another embodiment of the present technology. 106A and 106B are schematic cross-sectional views of an embodiment of a prosthetic heart valve device according to the present technology. 107A and 107B are isometric views illustrating a method of delivering a prosthetic heart valve device according to a further embodiment of the present technology.

  Specific details of some embodiments of the technology are described below with reference to FIGS. Many of the embodiments are described below with respect to devices, systems, and methods for percutaneous replacement of a natural mitral valve using a prosthetic valve device, but in addition to those described herein, Other applications and other embodiments are within the scope of the present technology. In addition, some other embodiments of the technology may have different configurations, components, or procedures than those described herein. Thus, those skilled in the art can have other embodiments with additional elements, or features that are shown and described below with reference to FIGS. 1-107B. It will be appreciated that other embodiments without some of them may be included.

  With respect to the terms “distal” and “proximal” in this description, unless specified otherwise, the terms refer to the operator and / or vascular system or location within the heart and the prosthetic valve device and / or associated delivery. It can refer to the relative position of the part of the device. For example, in referring to a delivery catheter suitable for delivering and positioning the various prosthetic valve devices described herein, “proximal” refers to a position closer to the incision into the operator or vasculature of the device. “Distal” can refer to a location that is more distal from the operator of the device or further from the incision along the vasculature (eg, the end of the catheter). With respect to a prosthetic heart valve device, the terms “proximal” and “distal” can refer to the location of a portion of the device relative to the direction of blood flow. For example, proximal can refer to an upstream location or blood inflow location, and distal can refer to a downstream location or blood outflow location. For ease of reference, the same reference numbers and / or letters are used throughout the present disclosure to identify similar or similar components or features, but the use of the same reference numbers indicates that the parts are the same. It should not be implied that Indeed, in many of the embodiments described herein, identically numbered parts are distinctly different in structure and / or function. The headings provided herein are for convenience only

Overview Systems, devices, and methods are provided herein for percutaneous replacement of natural heart valves such as mitral valves. Some of the details described below are provided to illustrate the following examples and methods in a manner sufficient to enable those skilled in the art to practice, make, and use them. The However, some of the details and advantages described below may not be necessary to practice certain embodiments and methods of the technology. In addition, the technology may include other embodiments and methods that are within the scope of the claims but not described in detail.

  Embodiments of the present technology provide systems, methods, and devices for treating bodily valves, such as heart valves, including mitral valves. The device and method allow a percutaneous approach using a catheter that is delivered intravascularly through a vein or artery into the heart. In addition, the devices and methods allow other minimally invasive approaches, including transapical, transatrial, and direct aortic delivery of prosthetic replacement valves to target locations within the heart. The apparatus and method allow the prosthesis to be secured to the natural valve location by engagement with the annulus and / or the valve leaflet sub-annular surface. In addition, embodiments of devices and methods as described herein are known to access heart valves (eg, mitral or tricuspid valves) with antegrade or retrograde approaches and combinations thereof Can be combined with many known surgeries and procedures.

  The devices and methods described herein provide a valve replacement that has the flexibility to adapt and conform to a variable shape natural mitral valve anatomy while mechanically isolating the prosthetic valve from the anchored portion of the device. Provide the device. Some embodiments of the device effectively absorb the distortion forces applied by the natural anatomy. The device has the structural strength and integrity necessary to withstand the dynamic conditions of the heart over time, thus permanently securing the replacement valve and allowing the patient to substantially resume normal life. Enable. The devices and methods further deliver such devices in a minimally invasive manner, providing not only a new permanent replacement valve to the patient, but also a lower risk procedure and faster recovery.

  In accordance with various embodiments of the present technology, a device for repair or replacement of a natural heart valve is disclosed. The natural valve has an annulus and leaflets, and the device is configured to engage tissue above or below the annulus and deform to a non-circular shape to conform to the tissue. , Including an anchoring member having a first portion. The anchoring member can also include a second portion. The device also includes a valve support coupled to the second portion of the anchoring member and configured to support the prosthetic valve and having a cross-sectional shape. In various embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable so that the anchoring member has a non-circular shape. The prosthetic valve remains competent when deformed.

  Some embodiments of the present disclosure are directed to a prosthetic heart valve device for implantation in a natural mitral valve, the mitral valve having an annulus and a leaflet. In one embodiment, the device can have an anchoring member that can be positioned at a location between the leaflets, and the first portion of the anchoring member can be expanded to a dimension that is larger than the corresponding dimension of the annulus. is there. In this embodiment, upstream movement of the anchoring member is interrupted by engagement of the upstream portion with tissue on or near the annulus. The anchoring member can also include a second portion. The device can also include a valve support coupled to the second portion of the anchoring member, the upstream region of the valve support being spaced radially inward from at least the first portion of the anchoring member. . The valve support can be configured to support the artificial valve.

  In another arrangement, a device for implantation in a natural valve having an annulus and leaflet is an upstream end configured to engage an inwardly facing surface of the leaflet downstream of the annulus and a dual end having a downstream end. A curved anchoring member can be included and the upstream end has a larger cross-sectional area than the downstream end. The device can also include a valve support positioned within the anchoring member and configured to support the prosthetic valve. The valve support is connected to the securing member at a location substantially downstream from the upstream end and is not coupled to the securing member at the upstream end.

  Another aspect of the present disclosure is directed to a prosthetic heart valve device for repair or replacement of a patient's natural heart valve, the heart valve having an annulus and a leaflet. In one embodiment, the device includes an anchoring member having a first portion having a first cross-sectional dimension and a second portion having a second cross-sectional dimension that is smaller than the first cross-sectional dimension. The first portion is configured to engage the heart tissue and hold the anchor member in a fixed longitudinal position relative to the annulus. The device can also include a valve support coupled to the second portion of the anchoring member and configured to support the prosthetic valve. The valve support can be radially separated from the first portion of the anchoring member so that the first portion can be deformed inward without substantially deforming the valve support.

  In a further arrangement, the present disclosure is also directed to a device for implantation in a natural heart valve. The device includes an anchoring member having an upstream end configured to engage tissue above or downstream of the heart valve's natural annulus and a valve support configured to support the prosthetic valve. be able to. The valve support can be coupled to the anchoring member. In some arrangements, the anchoring member can resist upstream movement of the device without an element of the device extending behind the native leaflet.

  In another embodiment, the device can include an anchor member that can be positioned between the native leaflets. The anchoring member has a plurality of tissue engaging elements on the upstream end and / or on the outer surface configured to engage heart tissue on or near the annulus to prevent device movement in the upstream direction. Can have. The device may also include a valve support positioned within the interior of the anchoring member and coupled to a downstream portion of the anchoring member, the valve support being at least radially separated from the upstream portion of the anchoring member. .

  Further embodiments of the present disclosure include a device for repair or replacement of a natural mitral valve having an annulus and a pair of leaflets, including a support structure having an upper region, a lower region, and an interior that holds a prosthetic valve Is targeted. The device may also include an anchoring member that surrounds at least a portion of the support structure, the anchoring member being positionable between the leaflets and a plurality of flexible elements arranged in a rhombus pattern (e.g., Wire, laser cut metal element, etc.), upper portion, and lower portion. The upper portion of the anchor member engages the heart tissue on or near the annulus so that the proximal end of the flexible element points radially outward so as to prevent movement of the device in the upstream direction It can be flared outward in the proximal direction. The lower region of the support structure can be coupled to the lower portion of the anchoring member, and the lower region of the support structure can be mechanically isolated at least from deformation of the upper skirt portion of the anchoring member.

  Other embodiments of the present disclosure are directed to a prosthetic heart valve device having a cylindrical support and a securement defined by a structure separate from the cylindrical support. The cylindrical support can have a longitudinal axis and an interior along the longitudinal axis through which blood can flow. The anchoring body can have a non-circular cross section with an outwardly flared upstream end configured to engage the sub-annular tissue of the mitral valve. The anchoring body can also surround the cylindrical support and be connected to the support at the downstream end opposite the upstream end.

  In a further embodiment, the device can include an expandable valve support configured for placement between two leaflets. The support can have a first region, a second region, and an interior to which a valve can be coupled. The device can also include an anchoring member having a first portion and a second portion, the second portion being coupled to a second region of the valve support. The first portion of the anchoring member can extend outwardly away from the second portion. The anchoring member can have a first perimeter in the first portion that is configured to engage tissue on or near the annulus. The anchoring member can be mechanically isolated from the valve support such that a force exerted radially at or near the first circumference does not substantially change the shape of the valve support.

  An additional embodiment is directed to a device for treating a patient's heart valve that includes an inner frame and an outer frame coupled to the inner frame. The inner frame can have an outer surface and an inner surface configured to support the prosthetic valve. The outer frame can have an upper portion with a cross-sectional dimension that is larger than the corresponding cross-sectional dimension of the mitral annulus, such that the upper portion engages tissue at or below the mitral annulus. Configured. The upper portion can also prevent movement of the device in the upward or upstream direction during ventricular systole. Furthermore, the upper part of the outer frame can be mechanically isolated from the inner frame.

  In further embodiments, the device can include a cylindrical inner skeleton and an outer skeleton coupled to the inner skeleton and positionable between leaflets downstream of the annulus. The outer skeleton may be deformable to a non-circular cross section, while the inner skeleton remains substantially circular in cross section. The inner skeleton can have an interior to which a prosthetic valve can be connected. The outer skeleton can have a plurality of flexible elements (eg, wires, laser-cut metal elements, etc.), at least a portion of the flexible elements being a natural valve to prevent movement of the device in the upstream direction. It can be configured to engage the subannular tissue. In one embodiment, the plurality of flexible wires are arranged in a diamond configuration.

  In yet further embodiments, the prosthetic mitral valve device can include a valve support having upstream and downstream ends, an interior to which the valve can be coupled, and a perimeter. The device can also include an anchoring member having a skirted upstream portion and a downstream portion coupled around the valve support. The upstream portion can be mechanically isolated from the valve support and can be configured to engage the sub-annular tissue of the natural mitral valve. In addition, the device may be movable in a plurality of configurations, including a first configuration, in which the valve support and the anchoring member are radially contracted, the valve support having a first cross-sectional shape. . The device can also be moved to a second configuration in which the valve support and anchoring member are radially expanded and the valve support has a second cross-sectional shape. In addition, the device can be moved to a third configuration in which the anchoring member is engaged with and deformed by the sub-annular tissue while the valve support remains in the second cross-sectional shape. .

  In some embodiments, the device may comprise an atrial support that extends from the anchor member or valve support to a position at least partially upstream of the natural mitral annulus. The atrial dilator member has an atrial engagement structure adapted to engage the upstream surface of the annulus (eg, the supraannular surface) and / or the inner wall of the atrium to further stabilize or secure the device. You may prepare. For example, the atrial holder can prevent downstream movement of the device.

  Some embodiments of the device may further comprise one or more stabilizing members to prevent the device from tilting or being displaced laterally. The stabilizing member may comprise a plurality of arms extending radially outward from the valve support and / or the anchoring member. The arm may be configured to extend behind the native leaflet and / or engage the ventricular wall or papillary muscle.

  A further embodiment according to another aspect of the present disclosure is directed to a device for implantation in a natural mitral valve, the natural mitral valve having an annulus and a leaflet. The device can include a valve support having upstream and downstream ends, an interior to which a valve can be coupled, and an exterior surface, and is coupled to the first skirted upstream portion and the exterior surface of the valve support. And a first anchoring member having a first downstream portion. In other embodiments, the first downstream portion can be coupled to the inner surface of the valve support or, in some embodiments, to the end of the valve support. The device can also include a second anchoring member that at least partially surrounds the first anchoring member. The first upstream portion of the first anchoring member can be configured to mechanically isolate from the valve support and engage the natural mitral valve supra-annular tissue. The second anchoring member can have a second widened upstream portion and a second downstream portion coupled to the outer surface of the valve support, the second upstream portion being mechanically away from the valve support. And can be configured to engage the sub-annular tissue of a natural mitral valve.

  In yet further embodiments, the device for implantation can include a radially expandable anchoring member configured to engage natural tissue above or downstream of the annulus. The anchoring member can have a first longitudinal length on the side facing the back leaf and a second length on the side facing the front leaf. In certain embodiments, the first length can be greater than the second length so that occlusion of the left ventricular outflow tract (LVOT) is limited. The device can also include a valve support, or alternatively a prosthetic valve, coupled to the interior or to the end of the anchoring member.

  Other embodiments of the present technology provide a device for implantation in a natural mitral valve having an annulus and leaflets, the device comprising upstream and downstream ends, an interior to which the valve can be coupled, and an outer surface. Having a valve support. The device can also include an anchoring member having a skirted upstream portion and a downstream portion coupled to the outer surface of the valve support, the upstream portion comprising an upper ring and a lower ring coupled to the upper ring. Can have. The device can further include a plurality of flexible annulus engaging elements distributed around the circumference of the anchor member and connecting the upper ring to the lower ring. The lower ring is configured to move upstream toward the upper ring so that the annulus is received between the upper and lower rings and within the annulus engagement element.

  The present disclosure further provides systems for the delivery of prosthetic valves and other devices that use intravascular or other minimally invasive forms of access. For example, embodiments of the present technology provide a system for treating a patient's mitral valve where the mitral valve has an annulus. The system comprises a device for treating a mitral valve as described herein and a catheter having a lumen configured to hold the device within the catheter.

  In another aspect, a system for replacing a patient's natural valve is provided. The system can include an elongate catheter body having a distal end and a proximal end, and a housing coupled to the distal end of the catheter body and having a closed end and an open end. The system also includes a proximal end of the catheter body to move the housing axially relative to the plunger by moving the actuator and a plunger in the housing that is axially movable relative to the housing. And an actuator coupled to the plunger. The system can further include a prosthetic valve device having a folded configuration and an expanded configuration. The prosthetic valve device may be positionable within the housing in a folded configuration and may be releasable proximally from the housing by moving the actuator.

  In yet another aspect, embodiments of the present technology provide a method of treating a patient's heart valve. The mitral valve has an annulus and a leaflet connected to the annulus. The method can include implanting a device as described herein in or adjacent to the annulus. The device, in some embodiments, can include a valve support coupled to and thereby at least partially surrounded by the anchoring member. The anchoring member can be disposed between the leaflets, and an upstream portion of the anchoring member is configured to engage tissue above or downstream of the annulus to prevent movement of the device in the upstream direction. be able to. Furthermore, the valve support can be mechanically isolated from the anchoring member at least in the upstream part.

  In yet a further aspect, embodiments of the present technology provide a method for replacement of a natural mitral valve having an annulus and leaflets. The method may include positioning the device as described herein between the leaflets while the device is in a folded configuration. The method may also include allowing the prosthesis to expand so that the prosthesis anchoring member is in a sub-annular position that engages tissue above or downstream of the annulus. The anchoring member may have a diameter that is greater than the corresponding diameter of the annulus at a position below the annulus. The method may further include allowing expansion of the valve support within the anchor member, the valve support being coupled to the anchor member. In various embodiments, the valve support can be mechanically isolated from the anchoring member such that deformation of the anchoring member when the anchoring member engages tissue does not substantially deform the valve support. . In some arrangements, certain areas of the valve support may be deformed, but a suitable support area for holding the prosthetic valve is substantially such that the leaflet joint of the prosthetic valve is not compromised. Does not deform.

  The present disclosure further provides a prosthetic heart valve device that can include an anchoring member having a tubular fixation frame with an inlet end and an outlet end. The device also has a first portion that is coupled to the anchoring member and a second portion that is mechanically isolated from the anchoring member such that the inlet end of the anchoring member substantially substantiates the second portion. Tubular valve supports that can be radially deformed without mechanical deformation can also be included. The device can further include a valve coupled to the valve support. The valve may have at least one leaflet that is movable from a closed position where blood flow through the valve support is blocked and an open position where blood flow is allowed downstream through the valve support. it can. The device can also include an expansion member coupled to the stationary frame and extending radially outward therefrom. The deformable portion of the expansion member can be mechanically isolated from the anchoring member so that the deformable portion of the expansion member is radially deformable without substantially deforming the anchoring member.

  An additional aspect of the present disclosure is directed to a prosthetic heart valve device that can include a fixation member having a connection structure and a radially expandable fixation frame. The connection structure may have a first end coupled to the fixed frame, a second end coupled to the valve support, and a side that separates the fixed frame from the valve support. The device is also connected to the valve support and moves from a closed position where blood flow through the interior is blocked and an open position where blood flow through the interior is allowed in the direction of flow from the inlet end to the outlet end. A valve having at least one leaflet that is possible can be included. The device can further include an expansion member having an edge and a support structure coupled to the edge. The edge can include a sheet of flexible material coupled to the stationary frame and extending radially outward therefrom. In various embodiments, the support structure can be more rigid than the edges. In one embodiment, the edge may be deflectable relative to a fixed frame around an axis transverse to the direction of flow, the fixed frame deforming at least partially independently from the valve support. Configured.

  An additional prosthetic heart valve device can include an anchor member having a tubular anchoring frame with an interior and an upstream end and a downstream end, and a valve coupled to the anchor member. The valve has at least one leaflet movable from a closed position where blood flow through the interior is blocked and an open position where blood flow through the interior is allowed in the direction of flow from the upstream end to the downstream end. Can have. The device can also include an expansion member having an edge and an elastic support structure coupled to the edge. The edge can include a sheet of flexible material coupled to the anchor member near its upstream end and extending radially outward therefrom. The support structure can be structurally independent from the fixed frame. Further, the expansion member can be radially deformable without substantially deforming the anchoring member.

  In yet a further aspect, the prosthetic heart valve device can include an anchoring member having a radially expandable frame with an interior and having an upstream end and a downstream end. In some embodiments, the upstream end is configured to engage the natural annulus of the heart valve in the subject and / or to tissue located downstream thereof and at least to match the shape of the tissue. Including a tissue fixation portion configured to be partially deformable. The device is also positioned with respect to the anchoring member and from a closed position where blood flow through the interior is blocked and an open position where blood flow through the interior is permitted in the direction of flow from the upstream end to the downstream end. A valve can be included having at least one leaflet that is movable. The valve can be spaced inwardly from the tissue fixation portion of the anchoring member so that when the tissue fixation portion is deformed to conform to the shape of the tissue, the valve remains competent. The device can further include an expansion member flexibly coupled to a securing member proximate the upstream end of the expandable frame, the expansion member extending longitudinally along the direction of flow in a low profile configuration. And is biased to project laterally with respect to the direction of flow in the deployed configuration. The expansion member can be configured to deform relative to the expandable frame in the deployed configuration.

  An additional aspect of the present technology is directed to a method for replacing a natural heart valve. In one embodiment, the method includes positioning the prosthesis with a delivery device in the first heart chamber upstream of the natural annulus and the anchoring member of the prosthesis is at least partially folded when the prosthetic presence is in a folded configuration. Deploying the expansion member of the prosthesis in the first heart chamber such that the expansion member expands at least partially into an expanded shape while remaining intact. The method also moves the prosthesis and visualizes the indicator portion of the expansion member to cause deflection of the indicator portion of the expansion member by engagement with the wall of the first heart chamber surrounding the natural heart valve. And determining the position of the prosthesis relative to the natural annulus based on the deflection of the indicator portion. The method can further include deploying the fixation member of the prosthesis such that it expands into engagement with heart tissue downstream of the native annulus to secure the prosthesis in place.

  Another method of replacing a natural heart valve is to position the prosthesis with a delivery device in a first heart chamber upstream of the natural annulus, and when the prosthesis is in a collapsed configuration, Deploying the prosthetic expansion member in the first heart chamber such that the expansion member expands at least partially into an expanded shape while remaining folded. The method can also include deploying the prosthetic anchoring member such that it expands into engagement with heart tissue downstream of the native annulus to anchor the prosthesis in place. The method can further include allowing the expansion member to deform radially to a greater extent than any deformation of the anchoring member.

  An additional method of replacing a natural heart valve is to position a prosthesis folded with a delivery device in a first heart chamber upstream of the natural annulus and to leave the prosthetic fixation member at least partially folded. In some cases, deploying the prosthetic expansion member in the first heart chamber such that the expansion member expands at least partially into an expanded shape. The method also includes moving the prosthesis in a downstream direction so that the expanded expansion member folds inwardly at least partially and positions the fixation member in a desired location relative to the natural annulus. Can do. The method can further include deploying the prosthetic fixation member such that it expands into engagement with the heart tissue downstream of the native annulus to secure the prosthesis in place.

  The devices and methods disclosed herein can be configured to treat non-circular and asymmetrically shaped valves such as mitral valves and bi- or bicuspid valves. It can also be configured to treat other valves of the heart, such as a tricuspid valve. Many of the devices and methods disclosed herein further provide long-term (eg, permanent) and secure anchoring of the prosthesis, even under conditions in which the heart or natural valve can undergo progressive expansion or distortion. Can be provided.

Heart and Mitral Valve Physiology FIGS. 1 and 2 show a normal heart H. FIG. The heart comprises a left atrium that receives oxygen-rich blood from the lungs through the pulmonary veins PV and delivers this oxygen-rich blood through the mitral valve MV into the left ventricle LV. The left ventricle LV of a normal systolic heart H is illustrated in FIG. The left ventricle LV is contracted and blood flows outwardly through the aortic valve AV in the direction of the arrow. The mitral valve is configured as a “check valve” that prevents backflow when the pressure in the left ventricle is higher than the pressure in the left atrium LA, so that the reverse flow of blood through the mitral valve MV or “ "Backflow" is prevented.

  The mitral valve MV comprises a pair of leaflets with a free edge FE that evenly meet or “join” to close, as illustrated in FIG. The opposite end of the leaflet LF is attached to the surrounding heart structure through an annular region of tissue called the annulus AN. FIG. 3 is a schematic cross-sectional side view of the annulus and leaflet of the mitral valve. As shown, the opposite end of the leaflet LF passes through the annulus of dense connective tissue, called the annulus AN, which is distinctly different from both the leaflet tissue LF and the adjacent muscle tissue of the heart wall. Adhering to the structure. The leaflets LF and the annulus AN are composed of different types of heart tissue with various strengths, toughness, fibrosis, and flexibility. In addition, the mitral valve MV also presents a unique region of tissue interconnecting each leaflet LF to the annulus AN, referred to herein as the leaflet / annulus connecting tissue LAC (indicated by overlapping parallel lines). You may prepare. In general, the annulus tissue AN is tougher, more fibrous, and stronger than the leaflet tissue LF.

  Referring to FIG. 2, the free edge FE of the mitral leaflet LF includes a chordae CT (herein referred to as “chordae”) including a plurality of bifurcated tendons fixed over the lower surface of each leaflet LF. ) ") And is fixed to the lower part of the left ventricle LV. The chord CT is attached to the papillary muscle PM that extends upward from the lower wall of the left ventricle LV and the ventricular septum IVS.

  Referring now to FIGS. 4A-4B, some structural defects in the heart can cause mitral regurgitation. As shown in FIG. 4A, because insufficient tension is transmitted to the leaflet via the chordae, the torn chordae RCT can deviate from the leaflet LF2. While the other leaflets LF1 maintain a normal profile, the two leaflets do not meet properly and leakage from the left ventricle LV into the left atrium LA will occur as indicated by the arrows.

  Reflux also occurs in patients suffering from cardiomyopathy where the heart is dilated and the increased size prevents the valve leaflets LF from intermingling properly, as shown in FIG. 4B. The expansion of the heart enlarges the mitral annulus, making it impossible for the free marginal FEs to meet during systole. The free edges of the anterior and posterior cusps usually intersect along the junction line C as shown in FIG. 5A, but as shown in FIG. 5B, a significant gap G suffers from cardiomyopathy Can be left behind.

  Mitral regurgitation can also occur in patients suffering from ischemic heart disease where papillary muscle PM function is impaired as illustrated in FIG. 4A. When the left ventricle LV contracts during systole, the papillary muscle PM does not contract sufficiently to provide proper closure. Then, one or both of leaflets LF1 and LF2 deviate. Again, leakage occurs from the left ventricle LV to the left atrium LA.

  5A-5C further illustrate the shape and relative size of the leaflet L of the mitral valve. Referring to FIG. 5C, it can be seen that the overall valve has a generally “D” shape or a kidney-like shape with a major axis MVA1 and a minor axis MVA2. In healthy humans, the long axis MVA1 is typically in the range of about 33.3 mm to about 42.5 mm (37.9 +/− 4.6 mm) in length and the short axis MVA2 is Is in the range of about 26.9 to about 38.1 mm (32.5 +/− 5.6 mm). However, in patients with diminished cardiac function, these values can be greater, for example, MVA1 can be in the range of about 45 mm to 55 mm, and MVA2 is in the range of about 35 mm to about 40 mm. obtain. The junction line C is curvilinear or C-shaped, thereby defining a relatively large anterior leaflet AL and a substantially smaller posterior leaflet PL (FIG. 5A). Both leaflets appear generally crescent-shaped from above or at the atrium, with the anterior leaflet AL being substantially wider than the posterior leaflet in the middle of the valve. As shown in FIG. 5A, at the opposite ends of the joining line C, the leaflets join together at the corners called anterior-lateral commissure AC and posterior-medial commissure PC, respectively.

  FIG. 5C shows the shape and dimensions of the mitral annulus. The annulus is an annular region around the valve that is thicker and stronger than the fibrous tissue of the leaflets LF and consists of fibrous tissue that is distinct from the ventricular and atrial wall muscle tissue. The annulus includes a first apex portion PP1 and a second apex portion PP2 located along the intervertex axis IPD, and a first trough portion VP1 and a second trough portion VP2 located along the valley axis IVD. Along with it, it may include a ridge-like shape. The first and second apex portions PP1 and PP2 are higher in height relative to the plane containing the bottom of the two valley portions VP1, VP2, typically about 8-19 mm higher in humans, and therefore Give the valve an overall bowl-like shape. The distance between the first and second vertex portions PP1, PP2, referred to as the inter-vertex range IPD, is substantially greater than the valley range IVD, which is the distance between the first and second valley portions VP1, VP2. short.

  Those skilled in the art will appreciate that the patient dimensions and physiology may vary from patient to patient, and some patients may include different physiology, but the teachings as described herein are subject to various conditions of the mitral valve. It will be appreciated that it can be adapted for use by many patients having dimensions, shapes and shapes. For example, studies on embodiments have shown that some patients may have a long dimension across the annulus and a short dimension across the annulus with no well-defined vertices and valleys, It is suggested that methods and devices as described in the specification can be constructed.

Access to the Mitral Valve Access to the mitral valve or other atrioventricular valve can be achieved through the patient's vasculature in a percutaneous manner. Percutaneous typically refers to the location of a vascular system remote from the heart through the skin using a surgical incision or minimally invasive procedure such as, for example, the use of needle access through the Seldinger technique. Means that The ability to access the remote vasculature percutaneously is well known and described in the patent and medical literature. Depending on the point of vascular access, the approach to the mitral valve may be antegrade and may rely on entry into the left atrium by traversing the atrial septum. Alternatively, the approach to the mitral valve can be retrograde, entering the left ventricle through the aortic valve. Once percutaneous access is achieved, the interventional tool and support catheter (s) are advanced to the heart in the blood vessel in various ways as described herein and adjacent to the target heart valve May be positioned.

  Using the transseptal approach, via the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the atrial septum IAS, and into the left atrium LA above the mitral valve MV , Access is gained.

  As shown in FIG. 6A, a catheter 1 having a needle 2 may be advanced from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the atrial septum IAS, the needle 2 may be advanced through the septum, for example, in the fossa FO or foramen ovale into the left atrium LA. . At this point, the guide wire may be replaced with the needle 2 and the catheter 1 may be withdrawn.

  As shown in FIG. 6B, access through the atrial septum IAS is typically maintained by the placement of a guide catheter 4 on a guidewire 6 that is typically placed as described above. Also good. The guide catheter 4 provides subsequent access to allow the introduction of the device and replace the mitral valve, as will be described in further detail herein.

  In an alternative antegrade approach (not shown), surgical access may be obtained through an intercostal incision, preferably without removing the ribs, and a small perforation or incision may be added to the left atrial wall Good. A guide catheter may then be placed directly into the left atrium through this perforation or incision and sealed with a purse string suture.

  An antegrade or transseptal approach to the mitral valve as described above can be advantageous in many ways. For example, the use of an antegrade approach will typically allow for more accurate and effective centering and stabilization of the guide catheter and / or prosthetic valve device. Accurate positioning facilitates the accuracy of placement of the prosthetic valve device. An antegrade approach may also reduce the risk of damaging chordae or other subvalvular structures during the introduction and manipulation of catheters and interventional tools. In addition, the antegrade approach may reduce the risk associated with aortic valve crossing as in the retrograde approach. This may be particularly relevant for patients with prosthetic aortic valves that cannot be traversed without any or substantial risk of damage.

  An example of a retrograde approach to the mitral valve is illustrated in FIGS. The mitral valve MV may be accessed by an approach from the aortic arch AA, across the aortic valve AV and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through a conventional femoral artery access pathway as well as through a more direct approach via the brachial artery, axillary artery, radial artery, or carotid artery. Such access may be achieved through the use of a guide wire 6. Once in place, the guide catheter 4 may be tracked on the guide wire 6. Alternatively, a surgical approach may be taken through a chest incision, preferably through a perforation of the aorta itself, with the intercostal space removed without removing the ribs. Guide catheter 4 provides subsequent access to allow placement of the prosthetic valve device, as described in further detail herein.

  In some specific cases, a retrograde artery approach to the mitral valve may be selected with certain advantages. For example, the use of a retrograde approach can eliminate the need for transseptal perforation. The retrograde approach is also more commonly used by cardiologists and thus has the advantage of being familiar.

  An additional approach to the mitral valve is through transapical perforation, as shown in FIG. In this approach, access to the heart is obtained via a conventional thoracotomy or sternotomy, or a thoracic incision, which can be a smaller intercostal or subxiphoid or perforation. The access cannula is then placed through a perforation that is sealed by a purse string suture in the left ventricular wall at or near the apex. The catheter and prosthesis of the present invention may then be introduced into the left ventricle through this access cannula.

  The transapical approach is characterized by providing a shorter and straighter straight path to the mitral or aortic valve. Furthermore, because it does not involve intravascular access, transapical procedures are performed by surgeons who may not have received the necessary training in interventional cardiology to perform the catheterization required by other percutaneous approaches. Can also be done.

  Artificial therapy devices may be specifically designed for the approach or may be interchangeable between approaches. One skilled in the art can identify an appropriate approach for an individual patient and design a treatment device for the identified approach in accordance with the embodiments described herein.

  Prosthetic valve device orientation and steering can be combined with many known catheters, tools, and devices. Such orientation may be achieved by overall maneuvering of the device to the desired location and then precise maneuvering of the device components to achieve the desired result.

  Overall maneuvering may be accomplished in several ways. A steerable guidewire may be used to introduce the guide catheter and artificial therapy device into place. The guide catheter may be introduced, for example, using a surgical incision or Seldinger access to the femoral artery in the patient's groin. After placement of the guide wire, a guide catheter may be introduced at a desired location on the guide wire. Alternatively, shorter and differently shaped guide catheters can be introduced through other routes described above.

  The guide catheter may be pre-shaped to provide the desired orientation relative to the mitral valve. For access via the transseptal approach, the guide catheter is at its tip so that the distal end is oriented toward the mitral valve from the location of the septal perforation through which the guide catheter extends. It may have a curvilinear shape, a slope, or other suitable shape. For the retrograde approach as shown in FIGS. 7 and 8, the guide catheter 4 is configured to pivot toward the mitral valve MV after being placed over the aortic arch AA and through the aortic valve AV. It may have a pre-shaped J tip. As shown in FIG. 7, the guide catheter 4 extends downward into the left ventricle LV so that the orientation of the intervention tool or catheter is more closely aligned with the axis of the mitral valve MV and is J-shaped. You may comprise so that a structure may be comprised. In any event, the pre-shaped guide catheter may be configured to be straightened for intravascular delivery using a stylet or inflexible guidewire that is passed through the lumen of the guide catheter. . The guide catheter may also have a pull wire or other means to adjust its shape for finer steering adjustments.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods Embodiments of the technology as described herein are for treating one or more of the heart valves as described herein. In certain embodiments, it can be used for the treatment of mitral valves. Examples of prosthetic heart valve devices, system components, and related methods according to embodiments of the present technology are described in this section with reference to FIGS. Certain elements, substructures, advantages, applications, and / or other features of the embodiments described with reference to FIGS. 10A-56 may be mutually and / or according to additional embodiments of the technology. It will also be appreciated that the embodiments described with reference to FIGS. 57A-71 can be suitably interchanged, substituted, or otherwise configured with the embodiments described with reference to FIGS. Furthermore, suitable elements of the embodiments described with reference to FIGS. 10A-71 can be used as stand-alone and / or self-contained devices.

  Systems, devices, and methods are provided herein for percutaneous implantation of a prosthetic heart valve within a patient's heart. In some embodiments, methods and devices are presented for the treatment of valve disease by minimally invasive implantation of a prosthetic replacement heart valve. In one embodiment, the prosthetic replacement valve may be a prosthetic valve device suitable for implantation and replacement of the mitral valve between the left atrium and the left ventricle in the patient's heart. In another embodiment, the prosthetic valve device may be suitable for implantation or replacement of another valve (eg, bicuspid or tricuspid valve) in the patient's heart. FIG. 10A shows an isometric view of the prosthetic heart valve device 100 in the expanded configuration 102, according to an embodiment of the present technology, and FIG. It is the schematic of a figure. FIG. 10B also shows an embodiment of the expandable prosthetic valve device 100 implanted in the natural mitral valve region of the heart.

  As shown in FIG. 10A, the device 100 can include a flexible anchoring member 110 that at least partially surrounds and is coupled to the inner valve support 120. The device 100 can further include a prosthetic valve 130 that is coupled to, mounted on, or otherwise carried by the valve support 120. 10C-10F are side, perspective cut, top, and bottom views, respectively, of the prosthetic heart valve device 100 according to the present technology. The device 100 can also include one or more sealing members 140 and a tissue engaging element 170. For example, the sealing member 140 may, in one embodiment, prevent paravalvular (eg, prosthetic proximity) leakage between the device 100 and the natural tissue and / or between the anchoring member 110 and the valve support 120. , Around the inner wall 141 of the anchoring member 110 and / or around the outer surface 127 of the valve support 120. In another specific embodiment, as shown in FIG. 10A, the tissue engaging element 170 can be a spike disposed on the upstream perimeter 113 of the anchoring member 110 to engage the natural tissue, In this embodiment, it can extend through and / or radially outward to penetrate natural tissue to facilitate retention or maintain the position of the device at the desired implantation location. A tissue engaging element 170 may also be included around the outer wall 142 of the anchoring member 110 and outwardly engages and penetrates in some embodiments, a natural leaflet or other adjacent tissue. Can be extended to In addition, the valve support 120 is provided with an upstream end 121 to facilitate loading, holding, and deployment of the device 100 in and from a delivery catheter (not shown), as further described herein. A plurality of connecting features 180 such as small holes can be provided around the perimeter of the.

  The prosthetic heart valve device 100 may be movable between a delivery configuration (not shown), an expanded configuration 102 (FIG. 10A), and a deployed configuration 104 (FIG. 10B). In the delivery configuration, the prosthetic heart valve device 100 has a low profile that is suitable for delivery through a small diameter guide catheter positioned in the heart via the transseptal, retrograde, or transapical approach described herein. Have In some embodiments, the delivery configuration of the prosthetic heart valve device 100 is preferably about 8-10 mm for a transseptal approach to the mitral valve MV, about 8-10 mm for a retrograde approach, or transapical For the approach, it will have an outer diameter of about 8-12 mm or less. As used herein, “expanded configuration” refers to the configuration of the device when it is freely expanded to an unconstrained size without the presence of constraining or distorting forces. A “deployed configuration” as used herein refers to a device that has been expanded at the natural valve site and is subjected to the restraint or distortion forces exerted by the natural anatomy.

  Referring again to FIG. 3, “under the annulus” as used herein refers to a portion of the mitral valve MV located above or downstream DN of the face PO of the natural mouth. As used herein, the natural valve face PO is a plane that is substantially perpendicular to the direction of blood flow through the valve, containing either one or both of the long axis MVA1 and the short axis MVA2 ( FIG. 5C). Accordingly, the sub-annular surface of the mitral valve MV is the tissue surface located on the ventricular side of the face PO, and preferably faces substantially downstream toward the left ventricle LV. The annulus subsurface may be placed on the annulus AN itself or on the ventricular wall behind the natural leaflet LF, or either the inward IF or outward OF located below the face PO You may provide the surface of one natural leaflet LF. Thus, the sub-annular surface or sub-annular tissue may comprise the annulus AN itself, the native leaflet LF, the leaflet / annular connective tissue, the ventricular wall, or a combination thereof.

  During surgery, the prosthetic heart valve device 100 is in a desired location within the heart, such as a location within the heart near the mitral valve MV, while in a delivery (eg, folded) configuration within a delivery catheter (not shown). It can be delivered intravascularly. Referring to FIG. 10B, the device 100 can be advanced to a position within or downstream of the native annulus AN, where the device 100 can be expanded from the delivery catheter to expand toward the expanded configuration 102 (FIG. 10A). Can be released. Device 100 will engage the natural tissue at the desired location and will deform or otherwise change the shape of device 100 to deployed configuration 104 (FIG. 10B). Once released from the catheter, device 100 resists systolic force and at least a portion of flexible anchoring member 110 engages the sub-annular surface of the natural valve to prevent upstream movement of device 100. Can be positioned (FIG. 10B). In the embodiment illustrated in FIG. 10B, the upstream perimeter 113 of the anchoring member 110 is biased outwardly to the inward surface IF (FIG. 3) of the natural leaflet LF that is folded under the natural annulus AN. Engage. The leaflet LF engages the ventricle side of the annulus AN and is prevented from being further urged upstream, thus maintaining the anchoring member 110 below the surface of the natural annulus. The tissue engaging element 170 can penetrate the tissue of the leaflet LF and / or the annulus AN to stabilize and secure the device 100. However, in some embodiments, some portions of the anchoring member 110 may extend above the annulus AN and at least some portions of the anchoring member 110 are directed to the device 100 toward the left atrium LA. Engage tissue at a location below the annulus to prevent movement of the annulus. As shown in FIG. 10B, the leaflets LF can be positioned in parallel with the outer wall 142 of the fixing member 110 to form a blood tight seal with the sealing member 140. The tissue engaging element 170 applies pressure against the annulus AN or leaflet LF along the outer wall 142 of the anchoring member 110 to further stabilize the device 100 and prevent movement, or otherwise In an embodiment, they can be penetrated.

  According to aspects of the present technique, the proximal or upper end of the anchoring member 110 coincides with the irregularly shaped mitral annulus AN while in the deployed configuration 104 to anchor the device and paravalvular. The device 100 is effectively sealed against the natural annulus AN so as to prevent leakage. As further described herein, the anchoring member 110 can be attached to the heart such that the anchoring member 110 can adapt and / or match natural forces while the valve support 120 maintains its structural integrity. Mechanical isolation of the valve support 120 from the existing distortion forces. Thus, the anchoring member 110 may be sufficiently flexible and elastic and / or valve support in such a manner as to mechanically isolate the valve support 120 from forces exerted on the anchoring member 110 by natural anatomy. It can be connected to the body 120. Alternatively or in addition to the features described above, the valve support 120 may maintain its cylindrical or other desired shape, and the proper opening and opening of the prosthetic valve 130 housed within the valve support structure 120. It may be more rigid and / or have a radial strength that is superior to the radial strength of the anchoring member 110 to ensure closure. In some embodiments, the valve support 120 has a radial strength that is at least 100% greater than the radial strength of the anchoring member 110, or in other embodiments at least 200%, and in further embodiments at least 300% greater. . In one embodiment, the valve support 120 can have a radial strength of approximately 10N to about 12N. Thus, when deformed from its unbiased shape by exerting a radial compressive force on its circumference, the valve support 120 will be indicated by the anchoring member 110 for a given degree of deformation. About 2 to about 20 times greater than the hoop force.

  As shown in FIGS. 10A to 10F, the fixation member 110 has a downstream portion 111 and an upstream portion 112 opposite to the downstream portion 111 with respect to the longitudinal axis 101 of the device 100. The upstream portion 112 of the anchoring member 110 can be a generally outwardly oriented portion of the device 100, as shown in FIG. 10D. In one embodiment, the securing member 110 has a generally hyperboloid shape, such as a bilayer hyperboloid shape. In another example, the downstream portion 111 can be substantially circular in cross section while the upstream portion 112 can be substantially non-circular. In some embodiments, the anchoring member 110 is a series of circumferentially positioned, elastically connected, in some embodiments, circumferentially by a deformable and / or flexible connector 116. A flexible longitudinal rib 114 can be included. Once deployed, at least a portion of the upstream end of the longitudinal rib 114 engages the sub-annular surface of a natural valve (eg, a mitral valve). As described in more detail below, certain embodiments of the longitudinal ribs 114 are configured to penetrate the sub-annular tissue and anchor the device 100 to make it more stable.

  In addition, FIGS. 10A-10F also illustrate that the longitudinal ribs 114 and / or the circumferential connectors 116 may be arranged in various geometric patterns. In the embodiment shown in FIGS. 10A-10F, the connector 116 is formed in a chevron configuration. One skilled in the art will recognize that rhombus patterns, sinusoidal configurations, closed cells, open cells, or other circumferentially expandable configurations are possible. In some embodiments, the longitudinal ribs 114 may be divided along their length into a plurality of separate segments (not shown), for example, where the connectors 116 interconnect with the longitudinal ribs 114. Good. The plurality of connectors 116 and ribs 114 can be formed from a deformable material or from an elastic or shape memory material (eg, nitinol). In other embodiments, the anchoring member 110 can comprise a mesh or woven structure in addition to or instead of the longitudinal ribs 114 and / or the circumferential connectors 116. For example, the anchoring member 110 can include a tube or braided mesh formed from a plurality of flexible wires or filaments arranged in a rhombus pattern or other configuration. In another example, the metal tube can be laser cut to provide the desired rib or post geometry. The diamond configuration is sufficient in some embodiments to provide sufficient column strength to prevent movement of the device 100 relative to the annulus under the force of systolic blood pressure against the valve 130 mounted in the valve support 120. Can be provided. In certain embodiments, the anchoring member 120 can be formed of a pre-formed nitinol tube having a wall thickness of, for example, approximately 0.010 inches to approximately 0.030 inches.

  11A-11H illustrate several embodiments of a valve support 120 that can be used in the embodiment of the prosthetic heart valve device 100 shown in FIGS. 10A-10F. FIGS. 11A-11G are side and isometric views of the valve support 120 shown in the expanded configuration 102, and FIG. 11H shows another embodiment of the prosthetic heart valve device 100 deployed in the expanded configuration 102 in accordance with the present technology. 1 is an isometric view of an embodiment. FIG. Referring to FIGS. 10A-10F and 11A-11H together, some embodiments of the valve support 120 are circular, oval, elliptical, configured to support a tricuspid or other prosthetic valve 130, It may be generally cylindrical with an upstream end 121 and a downstream end 123 formed around the longitudinal axis 101 with a kidney shape, D-shape, or other suitable cross-sectional shape. In some embodiments, the valve support 120 includes a plurality of pillars 122 connected circumferentially by a plurality of struts 124. The pillars 122 and struts 124 can be arranged in a variety of geometric patterns that can expand and provide sufficient elasticity and column strength to maintain the integrity of the prosthetic valve 130. For example, the plurality of posts 122 can extend longitudinally across the plurality of rows of struts 124 to provide column strength to the valve support 120. However, in other embodiments, the valve support 120 can comprise a metal, polymer, or fiber mesh or woven structure.

In general, the plurality of pillars 122 can extend along an axial direction generally parallel to the longitudinal axis 101, and the struts 124 are circumferentially around the longitudinal axis 101 and transverse to the longitudinal axis 101. And can be extended. Posts 122 may extend vertically across the height H ₁ of the valve support 120 (FIG. 11A), or in another embodiment, the pillars 122, along the height H ₁ of the valve support multiple Independent discrete column segments (not shown). In one embodiment, the height H ₁ can be approximately 14 mm to approximately 17 mm. The struts 124 can form a series of rings around the longitudinal axis 101, each ring having a geometric shape that can be expanded in the circumferential direction. In the embodiment shown in FIGS. 11A, 11D, and 11H, the struts 124 are formed in a series of zigzags and are arranged in pairs 180 degrees out of phase with each other to form a series of diamonds. Alternative expandable geometries can include sinusoidal patterns, chevron configurations (FIG. 11B), closed cells (FIG. 11C), open cells, or other expandable configurations. A plurality of struts 124 can be attached to the plurality of pillars 122 to define a plurality of nodes 125 where the struts and pillars intersect. The plurality of struts 124 and the plurality of columns 122 can be formed from a deformable material or from an elastic or shape memory material (eg, nitinol).

  The anchoring member 110 and the valve support 120 may be made of the same material or, in some embodiments, different materials. In some embodiments, both the anchoring member 110 and the valve support 120 comprise an elastic biocompatible metal such as stainless steel, a nickel cobalt or cobalt chromium alloy such as MP35N, or a nickel titanium alloy such as nitinol. A superelastic shape memory material such as Nitinol allows the device to be folded into a very thin delivery configuration suitable for delivery through the vasculature via a catheter and is suitably sized to replace the target valve Self-expansion to a deployed configuration can be made possible. In some embodiments, anchoring member 110 and / or valve support 120 can be laser cut from a single metal tube to the desired geometry to create an interconnected strut tubular scaffold. The anchoring member 110 may then be molded into a desired configuration, such as a skirt, funnel-like, or hyperboloid shape, using known shaping techniques for such materials.

  11B-11E, the valve support 120 has an inner surface 126 and an outer surface 127, and the valve support 120 receives or supports the prosthetic valve 130 within the inner lumen of the valve support 120. , Configured to block retrograde blood flow (eg, blood flow from the left ventricle into the left atrium). Accordingly, the valve support 120 provides a scaffold capable of securing the artificial valve tissue and provides a scaffold having sufficient axial rigidity to maintain the longitudinal position of the artificial valve 130 relative to the anchoring member 110. can do. The valve support 120 is further circular (or other desired) to ensure that the leaflets 132 of the prosthetic valve 130 are joined or otherwise sealed when the device 100 is subjected to external radial pressure. Such a scaffold can be provided having a radial stiffness that maintains a In one embodiment, the valve support 120 is attached to the prosthetic valve, or in other embodiments a support region 145 along the longitudinal axis 101 that is configured to be aligned with the junction of the leaflets 132. (Shown in FIG. 11B).

  The valve 130 may comprise a temporary or permanent valve adapted to block upstream blood flow and allow downstream blood flow through the valve support 120. The valve 130 may also be a replacement valve that is configured to be placed in the valve support 120 after the device 100 is implanted in the natural mitral valve. The valve 130 can have a plurality of leaflets 132 and can be a variety of flexible and impermeable materials, including PTFE, Dacron®, pyrolytic carbon, or other living organisms such as pericardial tissue. It may be formed of a compatible material or biological tissue, or xenograft valve tissue such as porcine heart tissue or bovine pericardium. Other aspects of the valve 130 are further described below. An inner surface 126 within the lumen of the valve support 120 prevents blood flow from the inside of the valve support 120 to the outside of the valve support 120, where blood may leak around the exterior of the valve support 120. , Can be at least partially covered by the impermeable sealing member 140. In another embodiment, the sealing member 140 can be affixed to the outer surface 127 of the valve support 120, and in either embodiment can be formed integrally with the valve 130 or attached directly to the valve 130. . In additional embodiments, the sealing member 140 can be applied over at least a portion of both the inner surface 126 and the outer surface 127 of the valve support 120.

  As shown in FIGS. 11B-11H, the prosthetic valve 130 is sewn, riveted, glued, bonded, mechanically sewn to a post 122 or commissure mounting structure 128 that is configured to align with valve commissure C. Can be interlocked or otherwise fastened. Pillar 122 or commissure attachment structure 128 includes eyelets 129, loops, or other features formed thereon to facilitate attachment of sutures or other fastening means that facilitate attachment of prosthetic valve 130. Can do. In one embodiment, as shown in FIG. 11B, the mounting structure 128 is integrated into the structural frame of the valve support 120 such that the mounting structure 128 is distributed around the circumference of the valve support 120 and functions as a post 122. can do. In another embodiment shown in FIG. 11D, the attachment structure 128 can be an attachment pad formed on a portion of the pillar 122 (eg, along the upper end of the pillar 122). In the embodiment illustrated in FIGS. 11E-11G, the valve support 120 includes a support band 119 into which the mounting structure 128 is incorporated. In some embodiments, the attachment structure 128 may be integral with the support band 119 (eg, laser cut from a single metal tube to the desired geometry and interconnected with a longitudinal attachment structure. Create one or more tubular support bands with struts). In other embodiments, the support band 119 can be a separate component fastened to the attachment structure 128. In a further embodiment shown in FIG. 11H, the attachment structure 128 can be a separate structure that can be coupled to the post 122, post 124, or other component along the inner surface 126 of the valve support 120.

  As illustrated in FIG. 11C, the prosthetic valve 130 may also be attached to a sealing member 140 or sleeve attached to the inner surface 126 of the valve support 120, as described above. Once attached, the prosthetic valve 130 may be suitable for folding or compressing with the device 100 for loading into a delivery catheter (not shown). In one embodiment, the prosthetic valve 130 has a trilobal configuration, but various alternative valve configurations such as a bilobal configuration may be used. Design of the prosthetic valve 130, such as the choice of a trilobal versus bilobal configuration, can be used to determine the preferred shape of the valve support 120. For example, for a trilobal valve, the valve support 120 can have a circular cross section, while for a bilobal valve, alternative cross-sectional shapes such as an oval or D-shaped cross section are possible. In certain examples, the valve support can have a circular cross-sectional diameter of approximately 25 mm to approximately 32 mm, such as 27 mm.

  In some arrangements, the valve support 120 can have a permanent prosthetic valve pre-mounted therein, or the valve support 120 can follow the implantation of the device 100 with a natural mitral valve. And may be configured to receive a separate catheter delivered valve. In arrangements where a permanent or replacement valve is desired, the valve support 120 can further include a temporary valve pre-mounted within the internal lumen. If a period of time is desired between the placement of the device 100 and further implantation of the permanent prosthetic valve, a temporary valve sewn into the valve support 120 or otherwise fixed within the valve support 120 may be used. In the meantime, the regulation of blood flow can be ensured. For example, the temporary valve may be used over a period of about 15 minutes to several hours or up to several days. The permanent or replacement prosthetic valve may be implanted within the temporary valve or may be implanted after the temporary valve has been removed. Examples of preassembled percutaneous prosthetic valves can be found in, for example, Medtronic / Corevalve Inc. CoreValve ReValving® System from (Irvine, CA, USA), or Edwards-Sapien® valve from Edwards Lifesciences (Irvine, CA, USA). When adapted to receive a separate catheter delivered valve, the valve support 120 engages the catheter delivered valve and retains it in its internal lumen, Alternatively, it may have features such as an inwardly extending ridge, step, protrusion, or flap on its upper or lower end. Additional details and embodiments regarding the construction, delivery, and mounting of prosthetic, temporary, and replacement valves suitable for use with the prosthetic heart valve devices disclosed herein are incorporated by reference in their entirety. International PCT Patent Application No. PCT / US2012 / 043636 entitled “PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS” filed on June 21, 2012, incorporated herein.

  In some arrangements, the anchoring member 110 is defined by a structure that is separate from the valve support 120. For example, the anchoring member 110 can be a first or outer frame or skeleton, and the valve support 120 can be a second or inner frame or skeleton. Accordingly, the anchoring member 110 can at least partially surround the valve support 120. In some embodiments, the downstream portion 111 of the anchoring member 110 can be coupled to the valve support 120, while the upstream portion 112 does not excessively affect the shape of the valve support 120. Not connected or coupled to 120. For example, in some embodiments, the upstream portion 112 of the anchoring member 110 can be configured to engage and deform to conform to the natural tissue shape above or below the annulus, while the valve The cross-sectional shape of the support 120 remains sufficiently stable. For example, when the anchoring member 110 is deformed inward, the valve support 120 (eg, at least the upstream end 121) so that at least the upstream end 121 of the valve support 120 remains substantially undeformed. ) And can be spaced radially inward from the upstream portion 112 of the anchoring member 110. As used herein, “substantially undeformed” can refer to a situation where the valve support 120 is not engaged or deformed, or the valve support 120 is slightly Although it can be deformed, it can refer to a scenario where the prosthetic valve 130 remains competent in its original state (eg, the leaflets 132 are sufficiently joined to prevent retrograde blood flow). In such an arrangement, the leaflets 132 of the prosthetic valve 130 can be fully closed even when the device 100 is undergoing systolic pressure or force from the heart delivery action.

  The longitudinal ribs 114 and / or the circumferential connectors 116 are not as rigid as the pillars 122 and / or struts 124 of the valve support 120, and the greater flexibility of the anchoring member 110, and / or the valve support 120. Further stability with respect to shape and position may be possible. In some embodiments, the flexibility of the anchoring member 110 allows the anchoring member 110 to absorb distortion forces (while leaving the valve support 120 substantially unaffected). Creating a seal to allow device 100 to conform to the irregular non-circular shape of the natural annulus, promote tissue ingrowth and prevent leakage between device 100 and natural tissue it can. In addition, the device 100 is secured in a desired position, while maintaining a larger upstream deployment circumference 150 ′ than the natural annulus so that positioning under the annulus effectively prevents upstream movement of the device 100. The longitudinal ribs 114 and / or connectors 116 can be configured to urge radially outward against natural valves, ventricles, and / or aortic structures (described further below in FIG. 14C). ). Further, the longitudinal ribs 114 provide sufficient elasticity and column strength (to prevent longitudinal collapse or abduction of the anchoring member 110 and / or device 100 and to resist movement of the device in the upstream direction ( For example, it can have axial inflexibility.

  By structurally separating the anchoring member 110 from the valve support 120, the valve 130 and valve support 120 are exerted by distortion forces exerted on the anchoring member 110 by natural tissue, such as natural annulus and / or leaflets. Effectively mechanically isolated from radial compressive forces, longitudinal diastole and systolic forces, hoop stresses, and the like. For example, deformation of the anchoring member 110 due to natural tissue can change the cross-section of the anchoring member 110 (eg, to a non-circular or asymmetrical cross-section), while the valve support 120 is substantially undeformed. Also good. In one embodiment, for example, when the anchoring member 110 is coupled to the valve support 120 (eg, the downstream end 123), at least a portion of the valve support 120 can be deformed by a radial compressive force. However, the upstream end 121 of the valve support 120 and / or the valve support region 145 (FIG. 11B) is mechanically removed from the anchoring member 110 and the compression force so that at least the valve support region 145 can be substantially undeformed. Isolated. Thus, the valve support 120, and at least the valve support region 145, can maintain a circular or other desired cross section so that the valve remains stable and / or competent. The flexibility of the longitudinal ribs 114 contributes to the absorption of distortion forces and can also help to mechanically isolate the valve support 120 and the valve 130 from the anchoring member 110.

  At the upstream end of the device 100 oriented toward the left atrium, the valve support 120 is configured to lie below, horizontally, or above the uppermost end of the upstream portion 112 of the anchoring member 110. can do. The anchoring member 110 can be coupled to the valve support 120 at the downstream end of the device 100 that is oriented toward and inside the left ventricle. Alternatively, the anchor member 110 can be coupled to the valve support 120 anywhere along the length of the valve support 120. The valve support 120 and the anchoring member 110 may be formed by various methods known in the art, such as stitching, soldering, welding, staples, rivets or other fasteners, mechanical interlocking, friction, interference fit, or the like. They may be linked by any combination of the above. In other embodiments, the valve support 120 and the anchoring member 110 can be integrally formed with each other. In yet another embodiment, a sleeve or other multilayer structure (not shown) may be attached to both the anchoring member 110 and the valve support 120 to interconnect the two structures.

  12A-12C are side views of various longitudinal ribs 114 that flex in response to a strain force F, according to further embodiments of the present technology. The degree of flexibility of the individual longitudinal ribs 114 (and thus the anchoring members 110) may be consistent among all the ribs of the anchoring members 110, or alternatively, some ribs 114 may be identical It may be more flexible than the other ribs 114 in the anchoring member 110. Similarly, the degree of flexibility of the individual ribs 114 may be consistent throughout the entire length of the ribs 114, or the degree of flexibility may vary along the length of each rib 114. it can.

As shown in FIGS. 12A-12C, longitudinal ribs 114 (shown individually as 114A-114C) are responsive to distortion forces F that can be applied by surrounding tissue during or after implantation of device 100, It may be bent along their respective lengths. In Figure 12A, the ribs 114A, respectively, in response to upward or downward force F _1, 'down to, or position 75' position 75 'to be flexed upwardly. Similarly, in FIG. 12B, the rib 114B with a plurality of specific segments 85A, 85B, and 85C may flex in response to forces _{F 2} directed laterally inwardly / outwardly or to the right and left And / or may rotate. Specific segments 85A at the end of the rib 114B is separate from the lower specific segments 85B and 85C, in response to a force F ₂ directed laterally inwardly / outwardly or to the right and left It may bend and / or rotate (e.g., up to position 85A '). In other arrangements, segment 85A may bend and / or rotate with specific segment 85B or together with both segments 85B and 85C (not shown) (eg, to position 85AB ′). As shown in FIG. 12C, a rib 114C having a generally linear shape when in a relaxed state can also be bent by a curved shape to create a curvilinear shape, or in another embodiment not shown, 2 By bending to create two substantially straight segments, inward / outward, or left and right (eg, position 95 ′ or 95) in response to a laterally directed force F ₃ May bend and / or rotate.

  The individual ribs 114 also have various shapes and can be disposed at various positions around the circumference of the anchoring member 110. In some embodiments, the device 100 can include first and second plurality of ribs, wherein the first plurality of ribs has different characteristics than the second plurality of ribs. Various characteristics can include rib size, rib shape, rib inflexibility, expansion angle, and number of ribs within a given region of the anchoring member. In other embodiments, the longitudinal ribs can be unevenly or evenly spaced around the periphery of the anchoring member.

The ribs 114 may be formed in any number of overall cross-sectional geometries of the anchoring member 110, such as circular, D-shaped, oval, kidney-shaped, irregularly shaped, etc. Can be located around a circumference oriented along 101. 13A is a schematic cross-sectional view of a prosthetic heart valve device according to another embodiment of the present technology, and FIGS. 13B-13F illustrate various longitudinal rib configurations according to additional embodiments of the present technology. 1 is a partial side view of a prosthetic heart valve device. FIG. Referring to FIG. 13A, each rib 114 can comprise a plurality of straight segments, such as segments 85A and 85B. In the illustrated embodiment, the ribs segment 85B is (form example, an angle away from the longitudinal axis 101) by a first angle A ₁ makes an angle radially outward. The rib segment 85B extends upstream from its point of attachment to the valve support 120 at the downstream end of the segment 85B, thereby increasing the diameter D _{2 at} the upstream portion 112 of the anchoring member 110 and at the downstream portion 111. A conical or skirt shape is imparted to the anchoring member 110 with a smaller diameter D ₃ . In one embodiment, the upper rib segments 85A, an angle with a steep second angle _{A 2} than the lower rib segments 85B with respect to the longitudinal axis 101, in the upstream portion 112 of the fixing member 110, a wider flared An upstream portion 112A can be provided. In some arrangements, the wider skirted upstream portion 112A may enhance the seal between the anchoring member 110 and the natural tissue, while the downstream portion 111 has a systolic force exerted on the device 100. Sometimes, a stiffer geometry can be provided to resist upstream movement of the device 100. Alternatively, the ribs 114 can be arcuate over all or part of its length, as shown in the partial side view of FIG. 13B.

  In yet other embodiments, as illustrated by FIGS. 13C-13F, the rib 114 can have a more complex shape defined by a plurality of specific segments 85A, 85B, 85C, and the like. For example, as shown in FIG. 13C, the rib 114 has a linear rib segment 85C substantially parallel to the longitudinal axis 101 that is connected to a rib segment 85B that is straight and radially outward at its upstream end. In addition, the rib segment 85B is connected at its upstream end to a more vertical rib segment 85A that is substantially parallel to the longitudinal axis 101. Referring to FIG. 13D, the rib 114 is substantially parallel to the longitudinal axis 101 and connected at its upstream end to a linear radially outwardly extending rib segment 85A that is substantially perpendicular to the longitudinal axis 101. A straight rib segment 85B can be included. Referring to FIG. 13E, the rib 114 is substantially parallel to the longitudinal axis 101 and connected at its upstream end to a linear radially outwardly extending rib segment 85B that is substantially perpendicular to the longitudinal axis 101. A straight rib segment 85C can be included. The rib segment 85B can be further connected at its most radially outward end to a vertical rib segment 85C that is substantially parallel to the longitudinal axis 101. Referring to FIG. 13F, the rib 114 is substantially parallel to the longitudinal axis 101 and is connected at its upstream end to a radially outwardly extending rib segment 85C that is substantially perpendicular to the longitudinal axis 101. Shaped segment 85D. The rib segment 85C can be further connected at its most radially outward end to a straight vertical segment 85B that is substantially parallel to the longitudinal axis 101, 85B being its most radially outward end. , Connected to a segment 85A extending inwardly in a linear radial direction.

  In the embodiment illustrated in FIGS. 13C-13F, the ribs 114 can be coupled to the valve support 120 (eg, coupled to the post 122) in a manner that enhances mechanical isolation of the valve support 120. For example, the majority of each rib 114 upstream of the attachment point is movable and deformable relative to the valve support 120 such that the rib 120 is radially outward or circumferential with respect to the valve support 120. The ribs 114 may be attached to the valve support 120 near the downstream end of the ribs 114 to allow bending back and forth in the direction. In addition, one of ordinary skill in the art will appreciate that any or all of the rib segments may have a curvature in any of the embodiments illustrated in FIGS. It will be appreciated that any interconnection of the segments shown to be made can be curvilinear. Thus, any of these various geometries can be found in the valve support from the forces exerted on the anchoring member 110 by the natural tissue, with the anchoring member 110 conforming to the natural anatomy, resisting movement of the device 100. 120 and / or the prosthetic valve 130 contained therein may be configured to be mechanically isolated.

  The flexibility characteristics of the individual ribs 114 may allow the flexibility and conformability of the anchoring member 110 to engage and seal the device 100 against unequal and uniquely shaped natural tissue. it can. In addition, the flexibility can assist in creating a seal between the device 100 and the surrounding anatomy. 14A is a schematic top view of a natural mitral valve MV illustrating a short axis 50 and a long axis 55, and FIGS. 14B-14C cover a schematic view of a natural mitral valve MV, according to an embodiment of the present technology. FIG. 4 is a schematic top view of the fixing member 110 of the enlarged configuration 102 and the deployed configuration 104, respectively.

Referring to FIG. 14B, the upstream portion 112 (FIG. 10A) of the anchoring member 110 is more than the short axis 50 (FIG. 14A) of the natural annulus when the anchoring member 110 is in the expanded configuration 102 (shown as a dashed line). large, usually, smaller than the major axis 55 of the annulus may have an outer periphery 150 with a diameter D _1. In other embodiments, the anchoring member 110 may have a diameter D ₁ that is at least as large as the distance between the natural commissures C, and is as large as the long axis 55 of the natural annulus, Or it can be even larger. In some embodiments, the outer periphery 150 of the anchoring member 110 has a diameter D ₁ that is approximately 1.2 to 1.5 times the diameter (not shown) of the valve support 120 (or prosthetic valve 130). , 2.5 times larger than the diameter of the valve support 120 (or prosthetic valve 130). While conventional valves must be manufactured in multiple sizes to treat various sized diseased valves, the valve support 120 and prosthetic valve 130 are in accordance with aspects of the present technology a number of natural valve sizes. May be manufactured with only a single diameter to fit. For example, the valve support 120 and the prosthetic valve 130 need not precisely engage and adapt to the natural anatomy. In a specific example, the valve support 120 may have a diameter (not shown) in the range of about 25 mm to about 32 mm for adult patients. Also, according to aspects of the present technology, the anchoring member 110 may be provided in multiple diameters to fit various natural valve sizes, with a diameter ranging from about 28 mm to about 80 mm at the upstream end. Or in other embodiments it may be greater than 80 mm.

  The top view of the anchoring member 110 shown in FIG. 14C shows one or more that the anchoring member 110 is distorted into a deployed configuration 104 as shown by a thick line, relative to an enlarged configuration 102 as shown by a dashed line. FIG. 2 illustrates how flexibility and / or deformation of the longitudinal ribs 114 and / or rib segments of the first and second ribs 114 is possible. As shown in FIG. 14C, anchoring member 110 has a highly variable natural mitral valve tissue shape, as indicated by the dotted line when deployed or implanted under or beneath the mitral annulus. While the ribs 114 may conform to the MV, the overall shape of the anchoring member 110 may be expanded (eg, generally more oval or D-shaped, or other irregular, instead of the fully expanded configuration 102). Bend, twist, and stretch to have the (shape) configuration 104. Referring to FIGS. 14B-14C together, anchoring member 110 covers mitral commissure C in deployed configuration 104, while commissure C is unsealed or exposed in a more circular expanded configuration 102, potentially It will allow paravalvular leakage. The anchoring member 110 can also be pre-formed into a generally oval or D-shaped or other shape when under unbiased conditions.

  FIG. 15 is an isometric view of an embodiment of the prosthetic heart valve device 100 illustrated in a deployed configuration 104, according to an embodiment of the present technology. FIG. 15 illustrates a device 100 having a plurality of ribs 114, and the first set of ribs 160 may be configured to bend inward or compress toward the central longitudinal axis 101 of the device 100. The second set of ribs 162 can be configured to bend outward or bend in response to a distortion force present in the space below the annulus of the natural valve. As a result, the outer periphery 150 of the anchoring member 110 is distorted from a more circular shape in the enlarged configuration 102 as indicated by the dashed line to a generally more oval or D-shaped in the enlarged configuration 104 as indicated by the solid line, and thus It may coincide with the shape of the natural anatomy. In a further arrangement, the upstream portion 112 of the anchoring member 110 is sized slightly larger than the sub-annular space in which it is deployed so that the anchoring member 110 is compressed to a slightly smaller diameter in its deployed configuration 104. It may be determined. This is so that the sealing member section between adjacent ribs 114 bulges or curves inwardly or outwardly as shown in FIG. 15 and is loose enough to form a loose section Bi. , May cause a slight relaxation of the sealing member 142. Such a bulge can enhance the seal formed between the device 100 and the natural tissue, with the curvature of the relaxed sleeve segment Bi engaging and matching the mitral leaflet tissue. Therefore, some sequences may be desirable.

  As shown in FIG. 15, in the illustrated embodiment, the unbiased enlarged configuration of the valve support 120, which is circular in cross-section, remains substantially unaffected while the anchoring member 110 is natural. It matches the non-circular shape of the mitral annulus MV. Thus, the valve support 120 is mechanically isolated from these forces and maintains its structural shape and integrity. The mechanical isolation of the valve support 120 from the anchoring member 110 can be due to some aspects of the prosthetic heart valve device 100. For example, the relatively high flexibility of the anchoring member 110 compared to the lower flexibility of the valve support 120 significantly deforms when the anchoring member 110 is deployed and in operation ( For example, the valve support 120 can be substantially undeformed (e.g., approximately Circular). In addition, the radial spacing between the anchoring member 110 and the valve support 120, particularly at the upstream portion / upstream end where the anchoring member 110 engages the natural annulus and / or sub-annular tissue, is the valve support 110. This allows the anchoring member 110 to be deformed inward by a substantial amount without engaging the. Further, the anchoring member 110 may be located at a substantial distance in the longitudinal direction (eg, downstream of the anchoring member 110) from where the anchoring member 110 engages the natural annulus (eg, the upstream portion 112 of the anchoring member 110). Portion 111) can be coupled to the valve support 120 and the ribs 114 of the anchoring member 110 absorb much of these forces exerted on it rather than transmitting the distortion force directly to the valve support 120. Make it possible to do. Also, the coupling mechanism employed to attach the anchoring member 110 to the valve support 120 reduces the transmission of force from the anchoring member 110 to the valve support 120 (e.g., is flexible or movable). (As discussed further herein).

  In many embodiments, the anchoring member 110 can be sufficiently flexible so that it matches the natural mitral annulus when the anchoring member 110 is in the deployed configuration 104 (FIGS. 14C and 15). The anchoring member 110, when in the deployed configuration 104, urges radially outward against the natural annulus, leaflet, and / or ventricular wall directly below the annulus. It can be configured to remain biased toward its enlarged configuration 102 (eg, FIGS. 10A and 14B). In some arrangements, the radial force generated by the biased anchor member shape is slightly increased in the minor axis 50 of the natural valve (FIG. 14A) and / or the annulus shape is otherwise different. It may be sufficient to deform the natural anatomy so that it can be altered. Such radial forces can cause the device 100 to stick to resist movement toward the atrium when the valve 130 is closed during ventricular systole, as well as movement toward the ventricle when the valve 130 is open. Can be improved. In addition, the resulting compression fit between the anchoring member 110 and the leaflets and / or ventricular walls or other structures may facilitate long term coupling between the tissue and the device 100 by promoting tissue ingrowth and encapsulation. To help create.

  16A-17C illustrate a prosthetic heart valve device 100 configured in accordance with additional embodiments of the present disclosure. 16A-16C are top views of the prosthetic heart valve device 100 illustrated in an enlarged configuration 102, including features generally similar to those of the prosthetic heart valve device 100 described above with reference to FIGS. It is a 1st and 2nd side view. For example, the device 100 includes a valve support 120 and a prosthetic valve 130 housed within the internal lumen of the valve support 120. However, in the embodiment shown in FIGS. 16A-16C, the device 100 is oval so that the anchoring member 210 is suitable for engaging and matching tissue in the sub-annular region of the mitral valve. Or a fastening member 210 having a D-shaped upstream perimeter 213 and a plurality of elevations around the circumference 250 of the fastening member 210.

  Referring to FIGS. 16A-16C together, the device 100 can include a flexible anchoring member 210 that at least partially surrounds and is coupled to the valve support 120 in the downstream portion 211 of the anchoring member 210. The device 100 may also be around the inner wall 241 of the anchoring member 210 and / or to prevent paravalvular leakage between the device 100 and the natural tissue and / or between the anchoring member 210 and the valve support 120. Alternatively, one or more sealing members 140 may be included that extend around the outer surface 127 or the inner surface 126 of the valve support 120. In one embodiment, the sealing member 140 can wrap around and / or cover the upstream perimeter 213 of the anchoring member 210. For example, the sealing member 140 can be sewn, sewn, or glued to the walls 241, 242 and can have an extension (not shown) that folds over the upstream perimeter 213. In one embodiment, the sealing member 140 can be adhered to the opposite wall (eg, extending from the inner wall 241 to cover the upstream perimeter 213 and attached to the upper portion of the outer wall 242). However, in other embodiments, the sealing member 140 can have a longer free edge (not shown) when not attached. The free edge of the sealing member 140 may be suitable in some arrangements to prevent blood flow between the upper perimeter 213 and the natural tissue.

  As shown in FIGS. 16B-16C, the anchoring member 210 has a downstream portion 211 and an upstream portion 212 opposite the downstream portion 111 along the longitudinal axis 201 of the device 100. Similar to the anchor member 110 (FIG. 10A) of the device 100, the upstream portion 212 of the anchor member 210 can be a generally outwardly oriented portion of the device 100. In some embodiments, the anchoring member 110 is a series of circumferentially positioned elastically deformable, which can be a cross pattern around the circumference 250 of the anchoring member 210 to form a diamond pattern. Flexible ribs 214 can be included. In one embodiment, the ribs 214 can be flexible wires or filaments arranged in a diamond pattern or configuration. The diamond-shaped configuration is, in some embodiments, a natural annulus to prevent movement of the device 100 relative to the annulus under the force of systolic blood pressure on the valve 130 mounted in the valve support 120. And hoop strength sufficient to provide a frictional attachment to the leaflet tissue. In certain embodiments, the anchoring member 120 can be formed of a pre-formed nitinol tube having a wall thickness of, for example, approximately 0.010 inches to approximately 0.030 inches. The diamond pattern or configuration may include, for example, one or more rows of diamonds around the circumference 250 of the anchoring member 210, and in some embodiments, between approximately 12 and approximately 36 columns of diamonds.

  In some embodiments, the upstream perimeter 213 of the anchoring member 210 is not located in a single plane. For example, the ribs 214 can have a variable length and / or be variable such that the distance (eg, altitude) between the downstream perimeter 215 and the upstream perimeter 213 can vary around the circumference 250. Can be offset from each other by angle. For example, the upstream perimeter 213 can form a perimeter with a plurality of vertices 251 and valleys 252 (FIG. 16B) to conform to the shape of the natural mitral valve (see FIG. 5C). As used herein, “vertices” and “valleys” do not refer to the rhombus vertices and rhomboids of the rhombus pattern formed by the plurality of ribs 214, but by a high degree of change relative to the downstream perimeter 215. Refers to the portion of the upstream perimeter 213 that has the undulating shape that is formed. In one embodiment, the distance (eg, altitude) between the downstream perimeter 215 and the upstream perimeter can vary from about 6 mm to about 20 mm, and in another embodiment between about 9 mm to about 12 mm.

  In one embodiment, the upstream perimeter 213 of the anchoring member 210 can have two vertices 251 separated by two troughs 252. In some embodiments, the first vertex can have a different shape or elevation than the second vertex. In other embodiments, the shape of the valley 252 may be different from the shape of the opposite vertex 251. Therefore, the apex 251 and the valley 252 can be positioned asymmetrically around the circumference 250 of the fixing member 210 and molded. In various arrangements, the valley 252 can be configured to be positioned along the commissure region of the natural annulus and the apex 251 can be configured to be positioned along the leaflet region of the natural annulus. In one embodiment, the apex 251 can have a tip configured to be positioned near the midpoint region of the leaflet. The anchoring member is also typically circumferential when in the unconstrained position so that the more radially enlarged portion corresponding to commissure is lower than the less enlarged area near the center of the leaflets. Although symmetric in direction, it can form the aforementioned “vertices and valleys” when deployed with a non-circular annulus. Such an effect can be facilitated by the specific geometry of the ribs and the diamond pattern of the fastening members.

Referring to FIGS. 17A-17C, one specific example of anchoring member 210 has a first elevation E ₁ of about 7 mm to about 8 mm in the first and second regions 253, 254 of the anchoring member downstream perimeter 215. And the upstream perimeter 213. The first and second regions 253, 254 are configured to align with first and second commissures of the natural mitral valve (eg, anterolateral commissure AC and posterior medial commissure PC, FIG. 5A). The anchoring member 210 can also have a second elevation E ₂ between about 9 mm and about 11 mm in the third region 255 of the anchoring member 210 between the downstream perimeter 215 and the upstream perimeter 213, and the third region 255. Is configured to align with the anterior leaflet AL of the natural mitral valve (FIG. 5A). The anchoring member 210 further has a third elevation E ₃ between the downstream perimeter 215 and the upstream perimeter 213 in the fourth region 256 of the anchoring member 210 opposite the third region 255 of approximately 12 mm to about 13 mm. The fourth region 256 can be configured to align with the posterior leaflet PL of the natural mitral valve (FIG. 5A). Those skilled in the art, sophisticated _E 1, _{E 2,} and _{E 3} may have other measurements, in some embodiments, high _E 1, _{E 2,} and _{E 3} are mutually and the It will be appreciated that they can be different or the same.

In addition, the upstream perimeter 213 can form a perimeter that has a generally oval or D-shaped or other irregular shape to conform to the shape of the natural mitral valve. For example, referring to FIG. 17A, the upstream periphery 213 of the fixing member 210 may have a peripheral outer diameter _{D m1,} and a surrounding outer diameter _{D m1} perpendicular surrounding inner diameter _{D m @ 2.} In one embodiment, the peripheral outer diameter D _m1 is longer than the long axis MVA1 of the natural mitral valve (shown in FIG. 5C) when the device 100 is in the expanded configuration 102 (FIG. 17A). In another embodiment, the peripheral outer diameter D _m1 is smaller than the long axis MVA1 when the device 100 is in the expanded configuration 102. In such an embodiment, the device 100 has an outer periphery that is larger than the long axis MVA1 when the device is in a deployed configuration (eg, when engaged with tissue above or below a natural annulus, see FIG. 16E). It can be configured to have a diameter D _m1 . Further, the peripheral inner diameter D _m2 is shown in FIG. ). In one embodiment, the perimeter outer diameter D _m1 and / or the perimeter inner diameter D _m2 is about 2 mm to about 22 mm, or in another embodiment about the long axis MVA1 and / or the short axis MVA2 of the natural mitral valve, respectively. It can be 8mm to about 15mm larger. In some embodiments, the peripheral outer diameter can be from about 45 mm to about 60 mm, and the peripheral inner diameter can be from about 40 mm to about 55 mm.

  Referring again to FIG. 16C, the upstream portion 212 of the anchoring member 210 can be radially separated from the valve support 120 by the gap 257. In one embodiment, the gap 257 is at the anterior apex of the device 100 (eg, along the third region 255) rather than the side facing the posterior apex (eg, along the fourth region 256) of the device 100. Big on the facing side.

Referring again to FIGS. 16A and 16C, the valve support 120 can be oriented along the first longitudinal axis 101 and the anchoring member 210 can be oriented along the second longitudinal axis 201. The second vertical axis 201 can be offset from the first vertical axis 101. “Offset” can refer to an array in which the axes 101, 201 are parallel but separated so that the gap 257 can vary around the circumference 250 (FIG. 16C). FIG. 16D illustrates that the “offset” is such that the second axis 201 can be angled from the first axis 101 such that the anchoring member 210 is generally inclined relative to the valve support 120 (eg, the first FIG. 6 illustrates another embodiment that can refer to an arrangement in which the first and second axes 101, 201 are non-collinear or non-parallel. In one embodiment, the second longitudinal axis 201 is arranged with an inclination angle A _TL between 15 ° and 45 ° with respect to the first longitudinal axis 101.

  In additional embodiments, as shown in more detail in FIG. 18, the first and second regions 253 and 254 of the upstream perimeter 213 have a longitudinal axis 201 that is greater than the third region 255 and the fourth region 256. Can extend far from. For example, the anchoring member 210 can have a generally conical shape (shown in dotted lines) and have an upstream peripheral extension 258 in the first and second regions 253 and 254. In some embodiments, the third region 255 of the upstream perimeter 213 can extend further from the longitudinal axis 201 than the fourth region 256. In some arrangements, the third region 255 is sized and allowed to allow the anchoring member 210 to engage the inward surface of the anterior leaflet without substantially occluding the left ventricular outflow tract (LVOT). Can have a shape.

Referring to FIGS. 17A-17C together, the valve support 120 can be oriented along the longitudinal axis 101 and the upstream portion 212 of the anchoring member 210 extends outwardly from the longitudinal axis 101 by a gradual decrease angle _AT . Can do. In embodiments where the ribs 214 are generally outwardly curved from the downstream portion 211 to the upstream portion 212 (rather than linearly), the decreasing angle _AT is continuous between the downstream portion and the upstream portion. Can be changed. In some embodiments, the taper angle _AT may be the same around the circumference 250 of the upstream portion 212 of the anchoring member 210, but in other embodiments, the taper angle _AT is around the circumference 250. Can change. For example, in the first and second regions 253 and 254 (FIG. 17B), the anchoring member 210 can be configured to align with the front outer commissure AC and the rear inner commissure PC (see FIG. 5C), respectively. It may have a first decreasing angle A _T1 . Anchoring member 210 further fourth region 256 that can be configured in the third section 255 can be configured to match the anterior leaflet and the second tapering angles A _T2, to align with the posterior leaflet It may have a third tapering angle _{a T3} (FIG. 17C). In one embodiment, the taper angle can be between approximately 30 degrees and approximately 75 degrees, and in another embodiment, between approximately 40 degrees and approximately 60 degrees.

  One important aspect of having an asymmetrical rib length for the anchoring member is that one side or segment of the anchoring member is exposed from the delivery system before the other, allowing the physician to orient the device before full deployment. It is possible that different lengths can mean that the device can be deployed to optimize.

  These variations in the shape of the anchoring member can provide several functions. One is to ensure better fitting with the natural annulus. Another is to optimize the bending load on each rib and section of the anchoring member in the deployed position to partially minimize long term fatigue stress on the rib. A third reason is to ensure that the anchoring member does not impart an asymmetric force on the valve support member when deployed with the mitral annulus. The fifth is to reduce the force of the deployed device against the anterior leaflet so that the leaflet is not excessively displaced toward the aortic valve. By ensuring that the center of the anterior cusp is smaller and radially expanded, the radius of curvature of the circumference of the anchoring member is higher in that region, and Laplace's law makes the radial force in that region more Will be lower.

  FIG. 16E is a schematic top view of a natural mitral valve in the heart as viewed from the left atrium, showing the prosthetic treatment device 100 of FIGS. 16A-16C implanted in a natural mitral valve MV, according to an embodiment of the present technology. . Once deployed, as illustrated in FIG. 16E, at least a portion of the upstream end of rib 214 (shown in FIGS. 16B-16C) engages the sub-annular surface of the natural valve (eg, mitral valve). Match. As described in more detail below, certain embodiments of ribs 114 or 214 are configured to penetrate the sub-annular tissue and anchor and further stabilize device 100.

  While the anchoring member 210 is deformable in response to the strain exerted by the natural anatomy, the valve support 120 has sufficient rigidity to maintain a circular or other original cross-sectional shape and thus The proper function of the prosthetic leaflet 132 can be ensured when opening and closing. Such mechanical isolation from the anchoring member 210 is achieved by the valve support 120 having sufficient rigidity to resist deformation while the anchoring member 210 is being deformed, and in or within the valve support 120. It may be accomplished by selecting a location and means for coupling the valve support 120 to the anchoring member 210 to reduce the transmission of force through the anchoring member 210 to the contained prosthetic valve 130. For example, the valve support 120 may be coupled to the securing member 210 only at the downstream end 123 of the valve support 120, which is separated from the upstream end 121 where the securing member 210 engages the annulus. On the upstream end 121, the valve support 120 is not completely connected to the anchoring member 210 so as to allow deformation of the anchoring member 210 without affecting the shape of the valve support 120, and by the gap 257. It may be spaced radially from the anchoring member 210 (see FIGS. 16A-16C where the prosthetic valve 130 is located). Thus, the force exerted on the anchoring member 210 by the annulus can be absorbed by the flexible ribs 214 of the anchoring member 210 so as to reduce the transmission of such force to the downstream end 123 of the valve support 120. it can.

In some embodiments, it may be desirable to limit the distance that the device 100 extends into the left ventricle downstream of the annulus (eg, to limit occlusion of the left ventricular outflow tract (LVOT)). Thus, some embodiments of the device 100 may have a relatively low overall height (eg, altitude E ₁ , E ₂ , and so that the anchoring member 210 does not extend into the LVOT or occlude the LVOT. E ₃ , FIGS. 17B-17C) can be included. As shown in side view in FIG. 16B, for example, fixing member 110 has a lower overall height relative to the height _{H V} of the valve support 120 _{E L} (e.g., the upstream periphery 213 and downstream periphery 215 of the fixing member 210 Distance). In such an embodiment, the upstream perimeter 213 of the anchoring member 110 is directly below the natural mitral annulus and can be positioned adjacent to or within the natural mitral annulus while anchoring The downstream perimeter 215 of member 210 is configured to extend minimally into the left ventricle below the natural mitral annulus when device 100 is implanted. In some arrangements, the valve support 120 can be coupled to the anchoring member 210 to minimize protrusion into the left ventricle, and in some embodiments, through the face of the natural annulus. May extend upward into the left atrium.

Additional components and features suitable for use with a prosthetic heart valve device Additional components and features suitable for use with a prosthetic heart valve device (eg, device 100 described above) include Described herein. Although certain components and features are described with respect to a particular device (eg, device 100), the components and features are also suitable for use with other devices as further described herein. It will be appreciated by those skilled in the art that it can be obtained or incorporated with other devices.

  As discussed above with respect to FIG. 10A, some embodiments of the prosthetic heart valve device 100 include a sealing member 140 that extends around a portion of the anchoring member 110 and / or the valve support 120. it can. For example, the embodiment illustrated in FIG. 10A includes a perimeter and valve around the inner wall 141 of the anchor member 110 to prevent paravalvular leakage not only between the device 100 and the anatomy, but also through components of the device 100. A sealing member 140 is provided around the outer surface 127 of the support 120.

  19A-19C are isometric, side, and top views, respectively, of a prosthetic heart valve device 100 having a sealing member 140, according to further embodiments of the present technology. Referring to FIGS. 19A-19C together, the device 100 includes a sealing member 140 such as a skirt 144. The skirt 144 may be disposed on the outer wall 142 or may be disposed on the inner wall 141 at least partially covering the upstream periphery 113 of the anchoring member 110. Accordingly, the skirt 144 can be fixed and / or coupled to any surface of the anchoring member 110. The skirt 144 can also overlap the inner surface 126 (shown in FIG. 19A) and / or the outer surface 127 of the valve support 120. Variations of the skirt 144 and / or other sealing members 140 are (1) creating a blood flow blocking seal between the anchoring member 110 and the natural tissue, and (2) passing through the walls 141, 142 of the anchoring member 110. And / or can be configured to block blood flow through the surfaces 126, 127 of the valve support 120 and (3) block blood flow through the space between the valve support 120 and the anchoring member 110. . In some embodiments, the sealing member 140 can be configured to promote ingrowth of adjacent tissue. The sealing member 140 is between the anchoring member 110 and the valve support 120 and between the device 100 and the surrounding anatomy so that blood flow is restricted from flowing from the left atrium to the left ventricle through the prosthetic valve 130. Can serve to seal between. In addition, the sealing member 140 may provide circumferential support for the anchoring member 110 when in the expanded configuration 102 (FIGS. 10A, 16A, and 19A) or the deployed configuration 104 (FIGS. 10B and 16B). it can. In some embodiments, the sealing member 140 may further serve to attach the anchoring member 110 to the valve support 120. For example, the skirt 144 may be integrally formed with or otherwise attached to the sealing member 140 that is coupled to the inner wall 141 of the anchoring member 110 and coupled to the valve support 120. In other embodiments, the sealing member 140 can be used to connect the valve support 120 to a prosthetic valve 130 housed within the valve support 120. A sealing member 140, such as a skirt 144, can be coupled to the anchoring member 110 and / or the valve support 120 with sutures, rivets, or other known mechanical fasteners. In other embodiments, adhesives, glue, and other bonding materials can be used to connect the sealing member to the components of the device 100.

  20A is an isometric view of the prosthetic heart valve device 100 without the sealing member 140, and FIGS. 20B-20E are isometric views of the prosthetic heart valve device 100 with the sealing member 140, according to additional embodiments of the present technology. FIG. For example, FIGS. 20B-20C illustrate an embodiment of the device 100 where the sealing member 140 is a sleeve 146. The sleeve 146 is cylindrical and can include an impermeable sealing material that is configured to fit within or on various frames or skeletal structures of the device 100 as further described below. In FIG. 20B, the sleeve 146 is on the outer surface 127 of the valve support 120, but in FIG. 20C, the sleeve 146 is also disposed on the inner wall 141 of the anchoring member 110 and on the outer surface 127 of the valve support 120. The FIG. 20D illustrates an embodiment of the device 100 in which the sleeve 146 is disposed on the outer wall 142 of the anchoring member 110 and on the outer surface 127 of the valve support 120. Referring to FIG. 20E, the device 100 may also incorporate a sleeve 146 on both the outer wall 142 and the inner wall 141 of the anchoring member 110 and on the outer surface 127 of the valve support 120.

  Those skilled in the art can completely seal the walls 141, 142, or surfaces 126, 127, such as the skirt 144 and sleeve 146 shown in FIGS. 19A-20E, or in other embodiments, It will be appreciated that the anchoring member 110 and the walls 141, 142 and / or surfaces 126, 127 of the valve support 120 can be at least partially covered, respectively. Any combination of sealing members 140 is contemplated. In addition, the sealing member 140 can create a seal between the anchoring member 110 and the valve support 120 (eg, to cover the inner surface 141 of the anchoring member 110 and the outer surface 127 of the valve support 120). A single continuous sheet of fluid impervious material can be included. In various embodiments, a sealing member 140 such as a skirt 144 or sleeve 146 integrates with tissue to minimize paravalvular leakage and minimizes Dacron®, ePTFE, bovine pericardium, or other suitable Fibers such as flexible materials or other flexible and biocompatible materials can be included. In other embodiments, the sealing member 140 can include a polymer, a thermoplastic polymer, polyester, Gore-tex®, synthetic fiber, natural fiber, or polyethylene terephthalate (PET). The valve 130 may also be attached to the sealing member 140 or formed integrally with the sealing member 140.

  In a further embodiment, shown in FIGS. 21A-21F, the valve support 120 may comprise a fiber, polymer, or pericardial tubular member 148 with little or no metal or other structural support. Referring to FIGS. 21A-21B, the tubular member 148 can retain its shape and is strong enough to resist radial and axial tension during systole and axial compression during diastole. It may be a thicker and more rigid part of the sleeve 146. The leaflets 132 of the prosthetic valve 130 may be integrally formed with the tubular member 148 and sewn or otherwise attached thereto. In one embodiment, the tubular member 148 can be integrally formed with the outer portion 146A of the sleeve 146 that extends around the anchoring member 110 (shown in FIG. 21A), or in another embodiment, the tubular member 148. Member 148 can be a separate and / or thicker member that is sewn, joined, or otherwise fastened to sleeve 146 in a blood-tight manner. Tubular member 148 may optionally include a reinforcing member to provide it with greater strength and to help maintain a desirable shape suitable for operating valve 130. For example, a series of relatively inflexible longitudinal struts 190 of metal or polymer can be coupled to or embedded within the wall of the tubular member 148 (FIG. 21C) and / or the wire coil 192 can be tubular. It may extend around the wall of the member 148 or be embedded inside (FIG. 21D). In a further embodiment, a series of tethers 194 can be coupled between the outer portion 146A of the sleeve 146 and the tubular member 148 (FIG. 21E). In one arrangement, the tether 194 can extend at a downstream angle from the upstream portion 112 of the anchoring member 110 to prevent collapse or structural attenuation of the tubular member 148 during atrial systole. In yet another embodiment, a plurality of vertical septa 196 may be interconnected between the anchoring member 110 (and / or the sealing member 140 coupled to the inner wall 141 of the anchoring member 110) and the tubular member 148. (FIG. 21F). The plurality of vertical septa 196 connected between the anchoring member 110 and the valve support 120 can be flexible fiber or polymer, and in some embodiments, the same material used for the sleeve 146. possible. A septum 196 that can be folded with the anchoring member 110 in a thin delivery configuration (not shown) can also constrain outward deflection of the ribs 114 when the device 100 is in the expanded configuration 102.

  As described herein, the anchoring member 110 can be a separate structure or component from the valve support 120. In one embodiment, the anchoring member 110 can be coupled to the valve support 120, for example, at the downstream end 123 of the valve support 120, while the upstream portion of the anchoring member 110 remains uncoupled to the valve support 120. And / or can be otherwise mechanically isolated from the valve support 120. The anchoring member 110 can be coupled to the valve support 120 using a variety of mechanisms, including flexible or non-rigid coupling mechanisms. 22A-22G and 22I-22K allow relative movement between the downstream portion or anchoring member 110 and the valve support 120, or a valve from the anchoring member 110, according to additional embodiments of the present technology. FIG. 6 is an enlarged side view of various mechanisms for coupling the valve support 120 to the anchoring member 110 that otherwise provide mechanical isolation of the support 120.

  22A-22B illustrate the downstream end 326 of the rib 114 of the anchoring member 110 coupled to the post 122 of the valve support 120. FIG. In the first embodiment, the ribs 114 can be connected to the pillars 122 by sutures, wires, or other suitable filaments 310 that are wrapped around and tied to adjacent elements (FIG. 22B). In some embodiments, either or both of the rib 114 and the post 122 are configured to hold the filament 310 therein and prevent sliding along the rib 114 or the post 122. The filament 310 may have features such as 312 (FIG. 22C), loops or eyelets 314 (FIG. 22D), or grooves 316 that can be secured.

  In another embodiment shown in FIG. 22F, the ribs 114 are connected to the pillars 122 by rivets, screws, pins, or other fasteners 318 that pass through the ribs 114 and the alignment holes 319 in the pillars 122. Can do. Alternatively, as shown in FIGS. 22G-22H, the post 122 may have a cavity 320 in its outer wall configured to receive the downstream end 326 of the rib 144 and the two elements 114. , 122 can be fastened together by a filament or fastener 322. In this arrangement, the downstream end of the rib 114 engages the bottom of the cavity 320, thereby releasing the suture or fastener 322 from having to resist the systolic force exerted on the valve support 110. Most of such forces can be transmitted directly to the ribs 114.

  In a further embodiment, shown in FIGS. 22I-22J, the downstream end 326 of the rib 114 passes through a passage 324 formed through the post 122. The downstream end 326 is then secured to the post 122 by fasteners 328 or filaments such as those described above. In addition, because the ribs 114 are retained in the passages 324, the systolic load exerted on the valve support 120 can be transmitted directly to the ribs 114 rather than the fasteners 328. In yet another embodiment, shown in FIG. 22K, the downstream end 330 of the post 122 is formed with a hook or J-shape radially outward to form a channel 332 that can receive the downstream end 326 of the rib 114. To do. The ends 330, 326 of the two elements may be secured by fasteners 334 that pass through the ribs 114 and the holes 319 in the pillars 122. The systolic load applied to the column 122 can be transmitted directly to the rib 114 via the channel 332, releasing the fastener 334 from taking up most of the load.

  FIGS. 23A-23B illustrate a further embodiment of a mechanism suitable for coupling the anchoring member 110 to the valve support 120. In the embodiment shown in FIGS. 23A-23B, the circumferential connector 116 of the anchoring member 110 is coupled to the strut 124 of the valve support 120. For example, in FIG. 23A, the connector 116 is formed having an hourglass-shaped portion 336 that forms a waist 338 and an enlarged connector head 340 that forms a connector cell 341. The strut 124 similarly has an enlarged strut head 346 that forms a strut cell 347. The hourglass portion 336 of the connector 116 can be configured to pass through the strut cell 347 such that the strut head 346 extends around the waist 338 of the connector 116. The connector head 340 can be large enough to be prevented from being released from the strut cell 347. Further, the divergence angle of the connector segments 116 </ b> A and 116 </ b> B can prevent the column head 346 from sliding upward with respect to the connector head 340. In such an arrangement, the systolic load exerted on the valve support 120 in the upward direction can be transmitted to the connector 116 through the struts 124, and thus these forces are fixed to secure the device 100 in place. The ribs 114 are driven into the natural anatomy.

  In FIG. 23B, the connector 116 can be formed to have a downwardly extending loop portion 348 nested within a recessed portion 350 formed in the post 124. The loop portion 348 can be fastened to the concave portion 350 in a variety of ways, for example, with a suture 352 wrapped around each member 348, 350. In this arrangement, the systolic load applied to the valve support 120 in the upstream direction can be transmitted through the concave portion 350 to the loop portion 348 of the anchoring member 110.

  In other embodiments, the anchoring member 110 or selected components thereof can be integrally formed with the valve support 120. As shown in FIG. 24A, the ribs 114 of the anchoring member 110 are integrally formed with the pillars 122 of the valve support 120 with U-shaped bridge members 356 interconnecting the ribs 114 to the respective aligned pillars 122. can do. The ribs 114 may be circumferentially interconnected by an expandable connector 116 that is integrally formed therewith. Alternatively, in the embodiment shown in FIG. 24A, a plurality of separate bands or wires 358 extend around the circumference 150 of the anchoring member 110, each for example a hole 360 formed in each individual rib 114. By extending through it, it is slidably connected to the rib 114. A flexible band or wire 358 allows the rib 114 to be folded inward into a low profile delivery configuration (not shown) while limiting outward deflection of the rib 114 when in the expanded configuration 102. Alternatively, a wire or suture tether 361 can be coupled between individual ribs 114 and post 122 (shown in FIG. 24B) to limit outward deflection of ribs 114 when in expanded configuration 102. May be.

  In further embodiments, the sleeve 146 may be secured to the rib 114 in a manner that limits outward deflection of the rib 114 when the device 100 is in an expanded configuration (shown in FIG. 24C). The sleeve 146 may extend around the outside of each rib 114 as shown in FIG. 24C, for example, to constrain the outward expansion beyond a predetermined limit. Optionally, the sleeve 146 further extends between an inner portion 146B of the sleeve 146 that extends around the valve support 120 and an outer portion 146A of the sleeve 146 that extends around the anchoring member 110. A septum 359 may be included. The horizontal septum 359 can restrict the outward bending of the rib 114 more firmly. In some embodiments, the septum 359 also restricts blood flow into the cavity 163 and minimizes clot formation therein so that it is between the inner portion 146B and the outer portion 146A. The annular cavity 163 formed by the septum 359 can also be sealed. Alternatively, allow blood to flow into the enclosed cavity 163 to form a clot region, thereby limiting the deflection of the ribs 114 and making the device more rigid and secure An opening (not shown) may be formed in the sleeve 146 downstream of the septum 359. A septum 359, which can be a flexible fiber, polymer, or pericardial material, is located at the upstream end of the device 100 as shown or spaced further downstream from the upstream end 121 of the valve support 120. May be. In a further embodiment, shown in FIG. 24D, each individual rib 114 can be constrained within a passage 364 formed in the sleeve 146 by stitching or joining two layers of sleeve fiber together. In the enlarged configuration 102, the movement of the rib 114 can be limited with respect to the sleeve 146.

  FIG. 25A is a partial cross-sectional view of a prosthetic heart valve device 100 having an anchoring member 110 and a valve support 120, and FIG. 25B is an enlarged view of the designated box shown in FIG. 25A, according to an embodiment of the present technology. is there. As shown in FIGS. 25A and 25B, there may be a gap 108 between the valve support 120 and the lower portion 111 of the anchoring member 110. If gap 108 is present, gap 108 may be protected by sleeve 146 to prevent blood from leaking between anchor member 110 and valve support 120 in either the upstream or downstream direction. it can.

  26A-26D are schematic cross-sectional views of a prosthetic heart valve device 100 having an atrial holder 410 and implanted in a natural mitral valve MV, according to various embodiments of the present technology. 26A-26C illustrate a natural valve for the device 100 to engage the supra-annular surface of the annulus AN or other tissue in the left atrium to prevent downstream movement of the device 100 into the left ventricle. FIG. 10 illustrates several embodiments of the device 100 including an atrial holder 410 configured to assist the apex. In these arrangements, the annulus AN can be sandwiched between the uppermost circumference 150 of the anchoring member 110 and the bottom surface of the atrial holding body 410.

  As shown in FIG. 26A, one embodiment of the device 100 can include an atrial holder 410 coupled to or integrally formed with the inner valve support 120. An atrial holder 410 extends upstream through the annulus AN into the supra-annular space within the atrium and engages an annulus surface or other atrial tissue with a flange 420 that extends outwardly. be able to. In another embodiment shown in FIG. 26B, the atrial holder 410 is formed integrally with or with the valve support 120 (eg, comprising an upward extension of the pillar 122 or an upward extension of the anchoring member 110). A plurality of fingers 412 can be provided that can be coupled differently. The finger 212 is generally not covered or exposed in the left atrium, as illustrated in FIG. 26B, but in another embodiment, the finger 412 forms a conical shape, Around the outer or inner surface of the finger 412 to help seal the device 100 with natural tissue on the atrial side of the annulus AN and to help infuse blood into the prosthetic valve 130 (FIG. 10A). Can be covered with a sealing member (not shown), or a fiber, polymer sheet, or other coating of pericardial tissue. The fingers 412 may also include circumferential struts (not shown) that interconnect the fingers 412 to limit lateral deflection and enhance finger inflexibility. The fingers 412 are elastically shaped so that they can be straightened and deflected inward for delivery and released to an unbiased radially protruding outward position in the enlarged configuration 102 as shown. A memory material (eg, nitinol) can be included. For example, the finger 412 can have a finger tip 414 that is biased outward in the expanded configuration 102 and in some arrangements in the downstream direction. Withdrawing device 100 distally or downstream so that finger 412 is first released to engage the atrial side of annulus AN during delivery to the desired location within natural mitral valve MV. (Discussed in more detail below). This is a device for the natural valve to ensure that the anchoring member 110 is positioned on the ventricular side of the natural annulus AN but is not excessively expanded into the ventricle when extracted and expanded. Index at position 100.

  The atrial holder 410 may alternatively be an extension of the anchoring member 110. In one embodiment shown in FIG. 26C, the atrial holder 410 is depicted in a more vertical plane, but may alternatively be located in a plane that is more parallel to the plane of the natural annulus AN and through the annulus AN. A plurality of atrial loops 416 extending upstream and then radially outward to engage the annulus surface. The loop 416, which may comprise an extension of one or more ribs 114 of the anchoring member 110, is compressed into a thin shape for delivery and then released to expand to the radially expanded configuration shown in FIG. 26C. Elastic shape memory metals (eg, Nitinol) or other materials that can be included. Similar to the device 100 of FIG. 26C, FIG. 26D is also a cross-sectional view of the prosthetic heart valve device 100 that includes an atrial holder 410 formed by an extension of the anchoring member 110. As shown in FIG. 26D, the atrial carrier 410 has an anchoring member 110 with a flange 420 extending over the atrial side of the natural annulus AN to engage the supra-annular surface with a proximal region. Can include a cylindrical portion 418 extending upwardly through the natural annulus AN. Flange 420 can include an elastic shape memory material (eg, nitinol) that can be folded for delivery and expanded when deployed with native mitral valve MV. Cylindrical portion 418 and flange 420 are integrally formed with anchoring member 110 and may comprise, for example, an extension of rib 114, or in another embodiment, anchoring member 110 and / or valve support 120. It can be connected to one or more parts.

In other embodiments, the prosthetic heart valve device 100 assists in holding the device 100 in the desired location within the natural mitral valve, but does not substantially engage the atrium or supra-annular tissue. Features can be included. For example, FIG. 27 is a side view of anchoring member 110 having a vertical portion 422 at an upstream end 424 for engaging an annulus AN according to another embodiment of the present technology. The anchoring member 110 can include a lower portion 111 and an upper flared portion 112 that can be positioned at a location beneath the annulus between the leaflet LF and downstream of the annulus AN. The upstream portion 112 may be expandable to a larger dimension than the corresponding dimension of the sub-annular tissue and / or inwardly facing leaflet LF. The vertical portion 422 can be adapted within the annulus to engage the annulus AN around the entire upstream circumference 150 of the anchoring member 110. The vertical portion 422 corresponds to the annulus AN so that the radial expansion of the vertical portion 422 compresses the natural tissue outward to help hold the device in the desired location with the natural mitral valve. It may be expandable to dimensions larger than the dimensions. Optionally, anchoring member 110 can also include a plurality of tissue engaging elements 170, such as spikes. In one embodiment, the spikes (shown here as tissue engaging elements 170) are distributed around the circumference 150 of the upper portion 112 of the anchoring member 110 such that the spikes penetrate tissue at a location below the annulus. The anchoring member 110 can be configured to help resist movement in either the upstream or downstream direction.
Prosthetic heart valve device having a stabilizing member

  FIG. 28 stabilizes the device 100 at the native valve site and, in some embodiments, to help prevent tilting or lateral movement, or to prevent upstream or downstream movement of the device 100. 1 illustrates one embodiment of a prosthetic heart valve device 100 in an expanded configuration 102 that further comprises one or more stabilizing members 501. In some embodiments, the stabilization member 501 may comprise one or more arms 510 that extend from below or downstream portion 111 of the anchoring member 110. Arm 510 is configured to engage a natural tissue, eg, a leaflet, sub-annular tissue, or ventricular wall, either inside or outside the natural leaflet, depending on the configuration.

FIG. 29 is an enlarged schematic side view of a prosthetic heart valve device having an expanded arm, according to an embodiment of the present technology. As shown in FIG. 29, the individual arm 510 may include an arm main body 512, an arm extension 514, and an arm tip 516. The arm body 512 has an arm body length L ₁ and may be connected to the column 511 at the first joint 508. The post 511 can be the valve support post 122, the anchor member rib 114, and / or another feature of the device 100 (eg, post 124 or connector 116). A first arm angle A _A1 is formed by the intersection of the axes of the column 511 and the arm body 512, and the first arm angle A _A1 is such that the tip 516 has a desired location, eg, sub-annular tissue or natural leaflet. The arm 512 is selected to be positionable so that it can engage the natural tissue at the ventricular wall behind. 30A-30C are enlarged partial side views of a prosthetic heart valve device 100 having arms 510 coupled to the device at various angles relative to the longitudinal axis 101 of the device, according to further embodiments of the present technology. In one embodiment, the first arm angle A _A1 can be between about 10 degrees and about 45 degrees. In other embodiments, the first arm angle A _A1 may be an obtuse angle (FIG. 30A), a substantially vertical or approximately 90 ° angle (FIG. 30B), or an acute angle (FIG. 30C).

Referring again to FIG. 29, the arm body 512 can be connected to the arm extension 514 at the distal end of the arm body 512. The arm extension 514 can have an arm extension length L ₂ that can be selected or optimized to penetrate a natural tissue at a desired distance, such as about 0.5-2 mm. Arm extension portion 514 may extend from the arm main body 212 in the second arm angle _{A A2.} The second arm angle A _A2 is formed by the intersection between the arm extension 514 and the arm body 512 to provide a desired angle of engagement with natural tissue, such as about 100 ° to about 135 °. You can choose. In other embodiments, the arm extension 514 may be parallel or collinear with the arm body 512 (not shown) or may be eliminated entirely. The arm extension 514 terminates at the arm tip 516. In embodiments where there is no arm extension 514, the arm tip 516 can be the most distal portion of the arm body 512 (not shown).

The arm 510 extends from a first junction point 508 to an arm's most distal arrival point, which may be an arm tip 516 (shown in FIG. 29) along an axis parallel to the longitudinal axis 101 of the device 100. You may have arm height _HA1 . The arm height H _A1 is the arm tip 516 when the device 100 is in the desired longitudinal position relative to the natural mitral valve (eg, when the anchoring member 110 is engaged with the sub-annular tissue). Can be selected or optimized to engage a desired location within the sub-annular anatomy. The arm height H _A1 will depend on the overall height of the anchoring member 110 and / or the valve support 120 and the location of the junction 508. 31A-31C are enlarged partial side views of a prosthetic heart valve device having arms 510 of various lengths (L ₁ + L ₂ ) and thus having a variable height H _A1 . As shown, the arm height H _A1 is greater than the overall height H _{D1 of the} anchoring member 110 or valve support (represented by ribs 114) (FIG. 31A) and is represented by ribs 114. ) Between the respective heights H _D1 and H _V1 of the anchoring member 110 and the valve support 120 (represented by the column 122) (FIG. 31B), or the anchoring member 110 and the valve support (represented by the rib 114). Both can be less than 120 overall height H _D1 (FIG. 31C).

  Additional details and embodiments regarding the construction and attachment of an arm or other stabilizing member suitable for use with the device 100 can be found in the application filed June 21, 2012, the entire contents of which are hereby incorporated by reference. International PCT Patent Application No. PCT / US2012 / 043636 entitled “PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS”.

  32A, 32B, 32C, and 32D are cross-sectional views of the heart with an implanted prosthetic heart valve device 100 having an arm 510a disposed on the inwardly facing surface of the leaflet LF, FIGS. , 32B-1, 32C-1, and 32D-1 are enlarged views of arm 510a that engage the inwardly facing surface of the leaflets as shown in FIGS. 32A, 32B, 32C, and 32D, respectively. Embodiments of the prosthetic heart valve device 100 illustrated in FIGS. 32A-32D-1 may include a radially inner position of the leaflet LF, a radially outer position of the leaflet LF, or the inner and outer sides of the leaflet LF. The arm 510a is configured to expand to the combination. For example, FIGS. 32A and 32A-1 show an arm 510a that expands to engage the inwardly facing surface of the leaflet LF and shows an arm 510a that partially punctures the leaflet LF. In another embodiment illustrated in FIGS. 32B and 32B-1, arm 510a may completely penetrate leaflet LF. In a further example, the device 100 may incorporate an arm 510a that 1) fully penetrates the leaflet LF, and 2) partially punctures the sub-annular tissue (FIGS. 32C and 32C-1). Referring to FIGS. 32D and 32D-1, the device 100 can be configured to incorporate an arm 510a that completely penetrates both the leaflet LF and the annulus tissue of the mitral valve MV.

  33A-33C are schematic diagrams illustrating various embodiments of a tissue engaging element 170 for use with the prosthetic heart valve device 100 in accordance with the present technology. Tissue engaging element 170 has any feature that engages tissue in an atraumatic manner, such as a blunt element, or partially punctures or completely penetrates cardiac tissue, such as a heel or spike. Can be included. As used herein, “tissue engagement”, as shown in FIG. 33A, exerts a force on tissue T, but does not necessarily puncture tissue T, such as being atraumatic to tissue T. , Element 170. As used herein, “partially puncturing” refers to a tissue engaging feature that at least partially penetrates tissue T, but does not penetrate the opposing surface S, as shown in FIG. 33B. 170. As used herein, “fully puncture” refers to a tissue engagement feature 170 that can enter and exit tissue T as shown in FIG. 33C. “Puncture” alone may refer to either partial or complete puncture. Tissue engaging element 170 may apply spikes, folds, or any structure known in the art that is capable of puncturing heart tissue, or alternatively, applying pressure to heart tissue without puncturing the tissue. It may be in the form of any blunt or atraumatic feature configured. Further details regarding the positioning of such elements are described herein.

  34A, 34B, and 34C are cross-sectional views of the heart with an implanted prosthetic heart valve device 100 having an arm 510a with a tissue engaging element 170 disposed on the inwardly facing surface of the leaflet LF. 34A-1, 34B-1, and 34C-1 are enlarged views of an arm 510a that engages the inwardly facing surface of the leaflet LF as shown in FIGS. 34A, 34B, and 34C, respectively. As illustrated in FIGS. 34A-34C-1, tissue engaging element 170 may be in a downstream direction (FIGS. 34A and 34A-1), an upstream direction (FIGS. 34B and 34B-1), or a downstream and upstream direction (FIG. 34C). And 34C-1) can be incorporated onto and extend from arm 510a. In other embodiments, the tissue engaging element 170 can be incorporated into and extend from the anchoring member 110 and / or the components of the valve support 120 in either or both upstream and downstream directions. .

  FIGS. 35A-35C illustrate a mitral valve MV (shown in cross-section) in a deployed configuration 104 in which the device has an arm 510b for engaging the outward surface of the natural leaflet LF, according to various embodiments of the present technology. 1 is a side view showing a prosthetic heart valve device 100 implanted in FIG. FIG. 35A illustrates that the downstream end of device 100 (eg, a natural mitral valve downstream of the leaflet) is implanted so that leaflet LF is effectively clamped between arm 510b and outer wall 142 of anchoring member 110. 1 illustrates an embodiment of the device 100 that includes an arm 510b that extends from the ventricular end of the device and extends behind the leaflet LF. In another embodiment, as shown in FIG. 35B, the arm 510b may fold the leaflet LF within the space between the arm 510b and the outer wall 142 of the anchoring member 110. In a further embodiment illustrated in FIG. 35C, the arm 510b may also include a tissue engaging element 170. FIG. 35C-1 is an enlarged view of arm 510b with tissue engaging element 170 for engaging the outward surface of leaflet LF as shown in FIG. 35C. As shown in FIG. 35C-1, the arm 510b configured to engage the outwardly facing surface of the native leaflet LF has tissue on the inner surface of the arm 510b so that it is oriented toward the leaflet tissue. An engagement element 170 may be included.

  In accordance with another embodiment of the present technology, FIG. 36A is a side view showing a prosthetic heart valve device 100 implanted in a mitral valve MV (shown in cross section). The device shown in FIG. 36A has an arm 510b for engaging the outward surface of the natural leaflet LF and an arm 510a for engaging the inward surface of the natural leaflet LF. Inner / outer arms 510a, 510b further comprise tissue engaging elements 170 on the radially inner surface or radially outer surface of arms 510a, 510b, respectively, for engaging or puncturing leaflet tissue. May be. The arrangement of the inner / outer arms 510a, 510b around the circumference of the device 100 can be alternated in a pre-designed pattern. For example, the inner arms 510a can alternate with the outer arms 510b, as shown in FIG. 36B, or alternatively, the arms 510a, 510b can be configured depending on the placement of the device 100 and the natural posterior and anterior vertebrae. It may extend radially outward and / or radially inward at random or irregular spacing relative to the alignment with the apex.

  37A-37D are enlarged side views of additional embodiments of an arm 510 suitable for use with the prosthetic heart valve device 100 in accordance with the present technology. For example, in FIGS. 37A-37D, the arm 510 can have an overall profile similar to that of the anchoring member 110. The anchoring member 110 may include ribs having various shapes, sizes, and / or outwardly or inwardly oriented rib segments 85 to form the overall anchoring member profile. Thus, the arm 510 may also have various shapes, sizes, and / or outwardly or inwardly oriented arm segments that mimic the outer shape of the anchoring member 110. In some arrangements, the embodiment shown in FIGS. 37A-37D can be used between arms 510 and ribs 114 to match the leaflet tissue to the shape of anchoring device 110 for enhanced sealing and anchoring of the device. Configured to clamp leaflet LF and / or annulus AN tissue. For example, FIG. 37A illustrates one embodiment in which the arm extension 514 and / or the arm body 512 can partially mimic the shape of the rib 114 and / or the rib segment 85, and FIG. Another embodiment is illustrated in which 514 and / or arm body 512 more closely follows the shape of rib 114. The embodiment encompassed by FIGS. 37A-37B can be applied to the outward facing surface engagement arm 510b and / or the inward facing surface engagement arm 510a. In addition, as shown in FIGS. 37A-37B, the arm extension 514 can extend radially outward to be substantially parallel to the upstream segment 85A of the rib 114. The arm extension 514 extends partially along the length of the rib 114 and / or rib segment 85 (FIGS. 37A and 37C), or completely along the length of the rib 114 and / or rib segment 85. It can be constituted as follows. In FIG. 37D, the arm 510 is connected to the upstream portion of the first arm extension 514 and extends outwardly so as to be substantially parallel to the second rib segment 85B and the third rib segment 85A. Two arm extensions 518 are provided.

  In some embodiments, the prosthetic heart valve device 100 may incorporate multiple arms 510 around the circumference of the device 100, but in other embodiments, the device may be a group (eg, posterior leaflet and Multiple arms may be included in the first and second groups) to engage the anterior leaflet. In addition, arm 510 may extend from anchoring member 110 and / or valve support 120 independently of other components including other arms 510, as shown in FIG. 38A. In other embodiments, as shown in FIG. 38B, device 100 further includes at least one first arm 510x interconnected with at least one second arm 510y by interconnecting arm struts 520. May be included. The arm strut 520 can be configured to be circumferentially expandable and may connect all the arms 510 (eg, arms 510x and 510y) or one or more groups of arms 510. In some embodiments, the arm strut 520 can limit the outward extension of the arms 510x, 510y away from the device 100.

  According to aspects of the present technique, the arm 510 is coupled to and / or extends from a component of the device 100 symmetrically and / or asymmetrically around the circumference 150 of the device 100. Can do. 39A-39D are schematic top views of arm position patterns for ribs 114 of anchoring member 110 (eg, as shown in FIG. 38A). The arm 510 can incorporate a rib 114 (FIGS. 39A and 39C), can be in the same radial plane as the rib 114 of the anchoring member 110 (FIG. 39B), or can incorporate a rib 114 and Can be in the same plane (FIG. 39D). Furthermore, the arm 510 extends outside the enlarged outer periphery 150 of the fixing member 110 (FIG. 39B), extends inside the enlarged outer periphery 150 of the fixing member 110 (FIG. 39A), and has the same outer periphery 150 of the fixing member 110. (FIG. 39C), or a combination of these configurations (FIG. 39D).

  In the above embodiment, the arm 510 may be configured to engage tissue independently of deployment of the anchoring member 110. For example, a delivery catheter suitable for delivery of the prosthetic heart valve device 100 is equipped with a separate mechanism that is operable to deploy the arm 510 and anchoring member 110 individually or otherwise independently of each other. May be. In this way, the anchoring member 110 may first be released to engage the natural tissue so that the position of the device 100 can be assessed and adjusted by the operator until the desired final position is obtained. . Following deployment and positioning of the anchoring member 110, the arm 510 can be released to engage tissue. Such a deployment system and method is useful when the arm 510 is equipped with a tissue engaging element 170 that, once deployed, may prohibit any repositioning of the device 100. In some embodiments, anchoring member 110 will be equipped with atraumatic tissue engaging element 170 that does not penetrate tissue or prevent device transfer once anchoring member 110 is deployed. Thus, some embodiments of the device 100 may be repositionable even with the anchoring member 110 expanded, as long as the arm 510 is constrained in a non-deployed configuration, and the device 100 may be released when the arm 510 is released. It is permanently fixed only when it is done.

  Alternatively, or in addition to the tissue engaging element 170 present on the arm 510 as described above, the tissue engaging element 170 may be present on other components of the device 100. 40A-40E are side views of a prosthetic heart valve device 100 having tissue engaging elements 170 on various structures of the device 100 according to additional embodiments of the present technology. For example, the tissue engaging element 170 can be incorporated on the rib 114 of the anchoring member 110. FIG. 40A shows tissue engaging element 170 incorporated on upper rib segment 85A, and FIG. 40B shows tissue engaging element 170 incorporated on lower rib segment 85B. FIG. 40C illustrates an embodiment of the device having tissue engaging elements 170 along the entire rib 114. Although the tissue engagement element 170 is schematically illustrated in FIGS. 40A-40C, those skilled in the art will recognize that the various tissue engagement elements 170 (eg, atraumatic, It will be appreciated that any one of (partially puncturing, fully penetrating, etc.) or other embodiments may be a combination of different types of tissue engaging elements 170. In addition, tissue engaging element 170 is shown oriented in the upstream direction (eg, to prevent upstream movement of device 100), but in other embodiments, tissue engaging element 170 (eg, It can be oriented in the downstream direction (so as to prevent downstream movement of device 100) or in a combination of downstream and upstream orientation directions. The tissue engaging element 170 can be incorporated symmetrically around the circumference of the device 100, or in other embodiments, the tissue engaging element 170 can be incorporated asymmetrically. For example, in some embodiments, the tissue engaging element 170 can be on the side of the device 100 aligned with the posterior leaflet, but the wall separating the aortic valve from the left ventricle is the tissue engaging element. To be unaffected by 170, it may have a different arrangement on the side of device 100 that is absent or aligned with the anterior leaflet.

  FIG. 40D shows upstream of the ribs 114 that can be configured to penetrate completely or partially through the sub-annular tissue when the device 100 is deployed above or below the mitral valve annulus. 1 illustrates an embodiment of the device 100 having a tissue engaging element 170, such as a spike on the end 175. FIG. In some embodiments, the tissue engaging element 170 (eg, spike) can include a heel 176 or other feature for retaining the tissue engaging element 170 (eg, spike) in the tissue. In other embodiments, the tissue engaging element 170 (eg, spike) can be blunt so as to engage but not penetrate the sub-annular tissue. 40E-40G are enlarged side views of a tissue engaging element 170 (eg, spike) suitable for use on the upstream tip 175 of the rib 114. The device 100 having the tissue engaging element 170 on the upstream tip 175 can also incorporate features to limit the distance of penetration into the tissue. For example, the upstream tip 175 is short, eg, 1-5 mm, proximal to the tip of each tissue engaging element 170 to limit the distance that the tissue engaging element 170 can penetrate the sub-annular tissue. It can have a handle 177 formed at a distance (FIG. 40E). Alternatively, as shown in FIG. 40F, the depth of penetration of tissue engaging element 170 into tissue can be limited by positioning connector 116 at a desired distance from the tip of tissue engaging element 170. . In a further embodiment, shown in FIG. 40G, the sealing member 140 may be attached to the rib 114 such that the upstream edge 178 of the sealing member 140 can limit the depth of penetration of the tissue engaging element 170. An attachment feature such as a hole 173 configured to receive a suture to prevent the sliding of the sealing member 140 downward can secure the sealing member 140 securely from its upstream tip 175. May be formed in the rib 114 at a distance of

  Alternatively, a tissue engaging element 170, such as a step, ridge, or other protrusion, configured to exert a frictional force on heart tissue may also include one or more valve support struts 124, valve support struts 122, and It may be present on other components (eg, sealing member 140). These tissue engaging elements 170 can be placed over the outer portions of these features to extend outwardly to engage the natural leaflets and to stabilize the device 100 in the desired location. And can be configured to be firmly attached. Alternatively, ribs 114, so that the ridges, clumps, hairs, or other directional features allow movement relative to the natural tissue in one direction while limiting movement in the opposite direction. It may be formed on the surface of the connector 116 or the sealing member 140.

  Tissue engaging elements 170 on anchoring member 110 are configured to have a delayed deployment to allow the device to be repositioned or removed over a period of time until these elements are fully deployed. Can be wrinkles, spikes, or other retention features. For example, the tissue engaging element 170 may be constructed of a shape memory material (eg, nitinol) that is pre-shaped in a deployed configuration and adapted to hold the tissue engaging element 170 in natural tissue. The tissue engaging element 170 may be deformed into a contracted configuration that allows for removal from the tissue and held in this shape by a biodegradable material or adhesive. Once immersed in tissue, the material can erode over a period of time (eg, 10 minutes to 2 hours), allowing the tissue engaging element 170 to return to its unbiased deployed shape, Will assist in holding the tissue engaging element 170.

  Some examples of such delayed deployable tissue engaging elements 170 are shown in FIGS. In the embodiment of FIG. 40I, the tissue engaging element 170 is a laser-cut shape memory alloy shaft having a diamond-shaped window 451 in the vicinity of its distal tip 452, which may be sharp enough to penetrate tissue. 450. The shape is set so that the window 451 is biased towards opening in the enlarged configuration as shown in FIG. 40I. Prior to delivery of the device, window 451 may be closed in a pinched state and biodegradable glue 455 may be injected into window 451 to keep it in a closed configuration as shown in FIG. 40J. . Upon deployment of the device, the distal tip 452 can penetrate natural tissue, such as a leaflet or annulus, as shown in FIG. 40K. The glue 455 in the window 451 maintains it in a closed configuration for a period of time to allow the operator to reposition or remove the device if necessary. If left in place, the glue 455 will erode and allow the window 451 to reopen to the expanded configuration and retain the tissue engaging element 170 in the tissue as shown in FIG. 40L. .

  In the embodiment shown in FIGS. 40M-40P, the tissue engaging element 170 is biased to angle radially outward, as shown in FIG. 40M, and refers to the proximal direction. An arrowhead tip 453 having wings 454 is provided. Biodegradable glue or coating 455 is applied over the arrowhead 453 to keep the wing 454 in a radially contracted configuration, as shown in FIG. 40N. In the contracted configuration, device 100 is deployed such that tissue engaging element 170 punctures natural tissue, as shown in FIG. 40O. The bioerodible coating 455 then gradually erodes until the wing 454 allows it to return to the laterally expanded configuration shown in FIG. Hold.

  A further embodiment is shown in FIGS. In this embodiment, the tissue engaging element 170 comprises a helical tip 456 in an unbiased state. Biodegradable coating 455 may be used to hold helical tip 456 in a linear configuration, as shown in FIG. 40R. Tissue engaging element 170 penetrates tissue in a contracted configuration and allows tissue engaging element when bioerodible coating 455 is sufficiently eroded to allow helical tip 456 to return to its deployed configuration. 170 can be held in tissue.

  The prosthetic heart valve device 100 can also be configured with an additional tissue engaging element 170 for engaging the annulus. For example, FIG. 41 is an isometric view of a prosthetic heart valve device 100 having a plurality of annulus engagement elements 179, according to a further embodiment of the present technology. Annulus engagement element 179 is a C-shaped hook feature or other shape that allows element 179 to engage tissue on the annulus and a portion of the annulus and sub-annular tissue. possible. As shown, the annulus engaging elements 179 are symmetrically (shown in FIG. 41) or asymmetrically distributed around the upstream periphery of the anchoring member 110 and include ribs 114, connectors 116 (not shown), or sealing members. 140 can be connected. The annulus engaging element 179 also extends to the anchoring member 110 elsewhere downstream of the upstream perimeter 113, or in other embodiments, at least through the annulus surface PO (FIG. 3). It may be connected to a part of. In addition, the annulus engaging element 179 can be blunt (eg, to urge but not penetrate the annulus tissue), or either one or both of the on-annular or sub-annular surface It can be sharp to penetrate the upper annulus tissue. Annulus engagement element 179 positions device 100 at a desired location (eg, with anchoring member 110 below the annulus) and prevents movement of the device in either the upstream or downstream direction. It may be suitable for both.

  In another embodiment shown in FIGS. 42A-42B, the prosthetic heart valve device 100 can have a tissue engaging element 372 deployable from a plurality of tubular ribs 314. Referring to FIG. 42A, the prosthetic heart valve device 100 can have an anchoring member 110 having a plurality of tubular ribs 314 configured to hold a plurality of deployable tissue engaging elements 372. FIG. 42B is an enlarged view of tubular rib 314 and deployable tissue engaging element 372 held within lumen 316 of rib 314 and shown prior to deployment of element 372. The tissue engaging element 372 includes a shape memory material (eg, nitinol) configured to deploy to a pre-formed shape upon release of the tissue engaging element 372 from the inner lumen 316 of the rib 314. it can. Release of the tissue engaging element 372 can be accomplished by engaging the proximal end 374 of the tissue engaging element 372. For example, the proximal end 374 can be engaged during deployment of the device 100 to release the tissue engaging element 372 after the anchoring member 110 is positioned at a desired location below the annulus AN. . Tubular rib 314 may include a U-shaped deflector 318 and a pivot point 320 configured to guide tissue engaging element 372 distally through distal opening 315 of rib 314. As illustrated by the dotted lines in FIG. 42B, the engagement of the proximal end 374 of the element 372 penetrates the adjacent sub-annular tissue so that the tissue engaging element 372 from the distal opening 315 of the tubular rib 314. The distal end 376 of the Once deployed and withdrawn from the opposite surface S, such as the supra-annular surface, the tissue engaging element 372 can resist its withdrawal of the distal end 376 from the tissue, such as its spiral shape 378. It is possible to shift to the shape that has been made.

  According to another embodiment of the prosthetic treatment device 100, the tissue engaging element 170 can be incorporated into the sealing member 140 (eg, sleeve 146). 43A-43B are isometric and enlarged detail views of the prosthetic heart valve device 100 having a sealing member 140 configured with a tissue engaging element 170. FIG. 43A-43B together, the tissue engaging element 170 is sufficiently rigid and sharp enough to penetrate tissue that is woven into or otherwise coupled to the sealing member 140 material, a metal or polymer wire 178. Or a fiber can be provided. The sealing member 140 may then be configured so that the tissue engaging element 170 extends radially outward from the sealing member 140 and engages an adjacent leaflet or other tissue and / or the outer wall of the anchoring member 110. It can be attached to the inner walls 141, 142 and / or the inner and / or outer surfaces 126, 127 of the valve support 120.

  The tissue engaging element 170 may alternatively comprise an array of relatively short folds, tips, rods, tines, or similar protrusions configured to frictionally engage tissue, or a natural valve The surface of the tissue may be recessed or slightly penetrated to prevent movement of the anchoring member 110 relative to the cusp or annulus. These tissue engaging elements, in exemplary embodiments, can be polymeric or metallic, can be about 0.2-5 mm in length, and can be about 0.1-0.5 mm in diameter. It may be sufficiently flexible to deflect slightly upon engagement with tissue and may be distributed across the surface of the sealing member 140 at a density of 4-100 per square centimeter. The tissue engaging element 170 may be integrally formed with the material of the sealing member 140 and may be woven into such material or coupled to the sealing member 140 and riveted or otherwise fastened. It may be formed in a flexible sheet or placed on a flexible sheet. The tissue engaging element 170 preferentially points in the non-vertical direction, preferably in the upstream direction, so as to provide a higher retention force for movement in the upstream direction while allowing easier movement in the downstream direction. May be angled, curvilinear, or bent. In some embodiments, the tissue engaging element is biodegradable that persists after implantation for a time sufficient to allow tissue ingrowth or encapsulation to hold the device 100 in place. You may be comprised from material. The material of the tissue engaging element 170 and / or the sealing member 140 is also a permanent or temporary friction enhancing coating or adhesive that enhances retention until at least the device is sufficiently encapsulated in the tissue to prevent movement. It may be coated.

  44A-44F illustrate various device structures (collectively referred to as “STs”) such as struts, connectors, pillars, arms, and / or ribs that may be incorporated into device features such as anchoring member 110 or valve support 120. Is an enlarged side view of an embodiment of an additional tissue engaging element that can be incorporated on For example, the additional tissue engaging element may comprise one or more notch protrusions 350 (FIGS. 44A and 44B) instead of or in addition to the tissue engaging element 170. In the folded or linear configuration as shown by the side view of FIG. 44C, the notch projection 350 maintains a low undulation with respect to the surface of the structure ST so as to maintain a thin profile during delivery. As device 100 expands and structure ST changes to its deployed configuration (eg, curvature as shown in FIG. 44D), the protrusions separate from ST until higher undulations. The protrusion 350 may also be configured to grip the sub-annular tissue and pull the notch protrusion further away from the structure ST. The device structure ST may also be shaped to include sharp protrusions 352 along one or more of its edges or faces, as illustrated in FIG. 44E, or as shown in FIG. A sharp scale-like protrusion 354 may also be included.

  In addition to the stabilizing member 501 described above, the prosthetic heart valve device (eg, device 100) described herein may also be used to stabilize the anchoring member 110 and / or the valve support 120 and / or Or, support features such as tether 360 and sealing member septum 370 may be included to evenly spread the pressure gradient load over a larger area of device 100 (eg, during ventricular systole). Referring to FIG. 45A, one embodiment of the device 100 can incorporate a plurality of tethers 360 that at least loosely connect the upper portion 112 of the anchoring member 110 to the upstream end 121 of the valve support 120. In one embodiment, the tether 360 can include a single suture that advances continuously around the circumference 150 of the anchoring member 110. In another embodiment, device 100 may include several discrete lengths of suture tied between anchor member 110 and valve support 120. In one embodiment, the tether can be a suture comprising polytetrafluoroethylene (PTFE). In general, the tether 360 assists in distributing force evenly along the anchoring member 110 without deforming the valve support 120 or compromising the closure of the prosthetic valve 130. In some arrangements, the tether 360 can help limit the radial expansion of the upstream portion. Thus, even with the tether 360 incorporated, the valve support 120 remains mechanically isolated at least from the upstream portion of the anchoring member 110.

  FIG. 45B illustrates stability suitable for stabilizing anchor member 110 and / or valve support 120 and / or for evenly spreading pressure gradient loads over a larger area of device 100 (eg, during ventricular systole). Another embodiment of the forming member 501 is shown. As shown in FIG. 45B, the device 100 can include a plurality of sealing member septa 370 extending between the anchoring member 110 and the valve support 120. In the illustrated embodiment, the septum 370 includes a sealing member 140 such as a skirt 144 connected to the inner wall 141 of the anchoring member 110 and a sealing member such as a sleeve 146 connected to the inner or outer surfaces 126, 127 of the valve support 120. It may be an extension of the sealing member material configured to span between the members 140. Accordingly, the septum 370 can be formed of fibers or other flexible and biocompatible materials such as Dacron®, ePTFE, bovine pericardium, or other suitable material. Similar to the embodiment illustrated in FIG. 45A, the septum 370 applies a force evenly along the anchoring member 110 without deforming the valve support 120 or otherwise compromising the closure of the prosthetic valve 130. Can help distribute. In some arrangements, septum 370 can help prevent device 100 from turning over during ventricular systole. Thus, even if the septum 370 is incorporated, the valve support 120 is mechanically isolated at least from the upstream portion of the anchoring member 110.

  Each of the elements and members of the device 100 may include any number of suitable biocompatible materials, such as stainless steel, nickel titanium alloys such as Nitinol ™, cobalt chrome alloys such as MP35N, depending on the desired result. Made from other alloys such as ELGILOY® (Elgin, IL), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combinations of materials Also good. Arm member 510, sealing member 140, sleeve 146, anchoring member 110, and / or valve support 120, or other elements of device 100 may also include materials that promote tissue ingrowth (eg, Dacron®, Or may be covered with PTFE or the like.

Delivery System FIGS. 46A-46D illustrate one embodiment of a delivery system 10 suitable for delivery of the prosthetic heart valve device disclosed herein. As used with reference to the delivery system, “distal” refers to a position having a further distance from the handle of the delivery system 10 along the longitudinal axis of the system 10, and “proximal” refers to the system A position having a distance closer to the handle of the delivery system 10 along the 10 longitudinal axis.

  FIG. 46A illustrates one embodiment of a delivery system 10 that may be used to deliver and deploy an embodiment of the prosthetic heart valve device 100 disclosed herein through the vasculature to the patient's heart. The delivery system 10 may optionally include a guide catheter GC having a handle 12 coupled to the delivery shaft 16, which in one embodiment is 34F or less in diameter and in another embodiment is 28F or less. The guide catheter GC may be steerable in a configuration suitable for the particular approach to the target valve or may be pre-shaped. Delivery catheter 18 includes a flexible tubular outer shaft 19 that is disposed on the proximal end of guide catheter GC through hemostasis valve HV and extends to delivery sheath 20 where device 100 is positioned in a folded or delivery configuration 106. . The flexible inner shaft 28 is slidably positioned within the outer shaft 19 and extends through the device 100 to the nose cone 21 at the distal end. Inner shaft 28 has a guidewire lumen through which guidewire 24 can be slidably positioned. Device 100 is coupled to inner shaft 28 and is releasable from inner shaft 28 by release wire 30, as described more fully below. Delivery sheath 20 may protect and protect device 100 with its folded configuration 106 during delivery. The outer shaft 20 is coupled to a retraction mechanism 23 on the handle 14 of the delivery catheter 18. Various retraction mechanisms 23 may be used, such as an axially slidable lever, a rotatable rack and pinion gear, or other known mechanisms. In this manner, the outer shaft 20 may be retracted relative to the inner shaft 28 to release (eg, deploy) the device 100 from the sheath 20.

  FIG. 46B shows the distal end of the delivery catheter 18 with the sheath 20 cut away to illustrate the coupling of the device 100 to the inner shaft 28. A plurality of locking fingers 32 are coupled to the nose cone 21 and extend proximally through the interior of the valve support 120 of the device 100. As shown in FIG. 46C, a selected number of posts 122 of the valve support 120 have connecting elements 61 with tabs 34 cut from each post 122 at its proximal end. Tab 34 may be deflected inwardly from post 122 as shown in FIG. 46B and is configured to extend through window 42 in locking finger 32 as shown in FIG. 46D. The Release wire 30 passes through hole 40 in tab 34 and prevents tab 34 from being pulled out of window 42 to secure device 100 to inner shaft 28. The tension wire 30 can be tightly clamped between the tab 34 and the locking finger 32 so that friction temporarily prevents the tension wire 30 from sliding in the proximal or distal direction. In this manner, the sheath 20 is retracted relative to the device 100 to allow for expansion of the device 100 while the inner shaft 28 maintains the longitudinal position of the device 100 relative to the anatomy. May be. The puller wire 30 may extend proximally to the handle 14, for example, between the inner shaft 28 and the outer shaft 19, or within one or more designated lumens. A suitable mechanism (not shown) on the handle 14 may allow the operator to retract the release wire 30 proximally until it is disengaged from the tab 34. Thus, the device 100 can be released from the locking finger 32 and expanded for deployment at the target site.

  47A-47D are schematic cross-sectional side views of the heart H showing a transseptal or antegrade approach for delivering and deploying the prosthetic heart valve device 100. FIG. As shown in FIG. 47A, the guidewire 24 is routed in the right atrium RA intravascularly using any number of techniques, for example, through the inferior vena cava IVC or superior vena cava SVC, through the atrial septum IAS. You may be moved forward. The guiding catheter GC may be advanced along the guidewire 24 into the right atrium RA until it reaches the anterior side of the atrial septum AS, as shown in FIG. 47B. In this regard, the guidewire 24 may be replaced with a needle 25 that is used to penetrate the atrial septum IAS (FIG. 47C). The guiding catheter GC may then be advanced over the needle 25 and into the left atrium LA, as shown in FIG. 47D. The guide catheter GC may also have a distal end that is pre-shaped or steerable to shape or steer the guide catheter GC to direct the delivery catheter 18 (FIG. 46A) toward the mitral valve. Good.

  As an alternative to the transseptal approach, the mitral valve may be accessed directly through an incision in the left atrium. Access to the heart may be obtained through an intercostal incision in the chest without removing the ribs, and a guide catheter may be placed into the left atrium through an atrial incision sealed with a purse string suture. The delivery catheter may then be advanced through the guiding catheter to the mitral valve. Alternatively, the delivery catheter may be placed directly through the atrial incision without using a guide catheter.

  48A-48C are cross-sectional views of the heart illustrating a method of implanting the prosthetic heart valve device 100 using a transseptal approach. 48A-48C together, the distal end 21 of the delivery catheter 18 may be advanced proximate to the mitral valve MV. Optionally, a guide wire GW may be used, as shown in FIG. 48A, where the catheter 18 can be slidably advanced over the guide wire GW. The sheath 20 of the delivery catheter 18 containing the device 100 in the folded configuration 106 is advanced through the mitral annulus AN between the native leaflets LF, as shown in FIG. 48A. 48B, the sheath 20 is then pulled back proximally with respect to the distal nose cone 27 so that the anchoring member 110 folds under the mitral annulus AN by urging the leaflet LF outward. In addition, the device 100 can be enlarged. The tips of the ribs 114 may penetrate into or through the leaflet tissue to engage the leaflet tissue and further engage the tissue of the annulus AN. After the sheath 20 is removed and the device 100 is expanded, the delivery system can still be connected to the device 100 so that the operator can further control the placement of the device 100 in the expanded configuration 102 (eg, (A system eyelet not shown is connected to the device eyelet 180 shown in FIG. 10A). For example, device 100 may be expanded upstream or downstream of the target location and then urged downstream or upstream into the desired target location, respectively, prior to releasing device 100 from delivery system 10. Once the device 100 is positioned at the target site, the puller wire 30 (FIGS. 46A-46B) may be retracted proximally to disconnect the device 100 of the deployment configuration 104 from the delivery catheter 18. The delivery catheter 18 can then be removed as shown in FIG. 48C. Alternatively, the device 100 may not be connected to the delivery system 10 so that the device 100 is deployed and fully released from the delivery system 10.

  49A and 49B illustrate another variation for delivering and deploying one or more prosthetic heart valve devices 100 using a retrograde approach to the mitral valve via the aorta and left ventricle. In this example, the guidewire GW may be advanced intravascularly into the left ventricle LV of the heart H from the femoral or radial artery or through direct aortic puncture through the aorta AO and the aortic valve AV ( FIG. 49A). Guide catheter GC, or alternatively, delivery catheter 18 is advanced along guidewire GW until the distal end is positioned in the left ventricle proximate to mitral valve MV, as shown in FIGS. 49A and 49B. May be allowed. In many arrangements, the guide catheter GC and / or delivery catheter 18 has a steering mechanism or pre-shaped distal tip that allows it to be steered from the aortic valve AV to the mitral valve MV with a 180 ° pivot. Will. The distal end of the delivery catheter 18 may optionally be advanced at least partially through the mitral valve MV and into the left atrium LA.

  50A-50B illustrate delivery of the device 100 of the folding configuration 106 to the mitral valve MV in a transapical approach. Referring to FIG. 50A, delivery catheter 18 is advanced through guide catheter GC inserted into the left ventricle of the heart through a perforation in the left ventricular wall at or near the apex. The catheter can be sealed with a purse string suture. Alternatively, delivery catheter 18 may be placed directly through a transapical incision sealed with a purse string suture without a guiding catheter. The sheath 20 and the device 100 within the sheath 20 (eg, in the folded configuration 106) are advanced through the mitral annulus AN between the natural leaflets LF, as shown in FIG. 50A. Referring to FIG. 50B, the sheath 20 is pulled proximally so that the device 100 expands to the expanded and / or deployed configuration 102,104. The delivery system 10 can remain connected to the device 100 after removal of the sheath 20 so that an operator can control the placement of the device 100 while in the expanded configuration 102 (eg, shown). A system eyelet that is not connected is connected to the device eyelet 180, FIG. 10A). The pull wire 30 may be retracted proximally to release the device 100 from the delivery system 10 so that the delivery system 10 is removed and the device is fully implanted in the mitral valve MV in the deployment configuration 104. Enable. In one embodiment, device 100 is expanded upstream or downstream of the desired target location and then retracted or pushed into the target location downstream or upstream, respectively, before releasing device 100 from delivery system 10. May be. Alternatively, the device 100 may not be connected to the delivery system 10 so that the device 100 is deployed and fully released from the delivery system 10.

  51A-51B are partial side views of the delivery system 10 in which the prosthetic heart valve device 100 is mounted on the expandable balloon 300 of the delivery catheter 18 according to another embodiment of the present technology. Referring to FIGS. 51A and 51B together, the device 100 rests on the delivery catheter expandable balloon 300 while in the folded configuration 106 for delivery to a desired location at or near the native mitral valve. (FIG. 51A). When device 100 is released from sheath 20 (FIGS. 46A-46B), device 100 can be expanded to its expanded configuration 102 by inflation of balloon 300 (FIG. 51B). When using the balloon 300 with the delivery system 10, the device 100 can be advanced from the delivery shaft 16 to initially position the device 100 at the target location. Balloon 300 can be inflated to fully expand device 100. The position of the device 100 relative to the mitral valve may then be adjusted using a device locking hub to position the device at the desired implantation site (eg, directly below the natural mitral annulus). In another embodiment, the balloon 300 can first be partially inflated to partially expand the device 100 in the left atrium. The delivery system 10 can then be adjusted to push or retract the partially expanded heart valve device 100 into the implantation site (depending on the approach), after which the device 100 is brought to its functional size. Can be fully enlarged. In another alternative method, the anchoring member 110 is a self-expanding construct that is first released from the sheath 20 at the target site to engage the natural anatomy (FIGS. 46A-46B), The valve support 120 is a balloon-expandable element mounted on the balloon 300 that is then expanded to fully deploy the valve support 120 after the anchoring member 110 is released.

  In still further embodiments, the valve support 120 of the device 100 may be configured to be axially movable or removable from the anchoring member 110. In such an arrangement, the two components 110, 120 may be loaded in an axially separated configuration within the delivery system 10, thereby reducing the overall profile of the system 10. After delivery to the target valve site, the components 110, 120 can be assembled together. 52A-52D show an embodiment of assembling the valve support 120 and anchoring member 110 in the heart. As shown in FIG. 52A, the delivery catheter 380 is advanced into the left atrium via a guiding catheter GC placed through the atrial septum or atrial wall. Delivery catheter 380 has split sheaths 382, 384 that comprise a distal nosecone 382 and a proximal capsule 384. Delivery catheter 380 is advanced through native valve MV until nose cone 382 is positioned distal to native annulus AN (FIG. 52A). The nosecone 382 is then advanced further distally while maintaining the position of the remaining portion of the delivery catheter 380, thereby releasing the anchoring member 110 from the nosecone 382 (FIG. 52B). The anchoring member 110 self-expands outward and engages the natural leaflet LF to fold them outward under the natural annulus AN as shown in FIG. 52B. The upstream tip of rib 114 (FIG. 52B) engages the sub-annular tissue to secure device 100 in place. The sealing member 140 is secured to the periphery 113 of the anchor member 110 and has a connecting portion 386 extending into the proximal capsule 384 where the valve support 120 is still constrained within the proximal capsule 384. Fixed. Delivery catheter 380 is then advanced to position proximal capsule 384 within anchor member 110, as shown in FIG. 52C. Proper positioning may be obtained by advancing the catheter 380 until the sealing member 140 is in a tensioned state. The proximal capsule 384 is then retracted relative to the nosecone 382 so as to release the valve support 120 from the proximal capsule 384. The valve support 120 is self-expanding to engage the downstream end of the anchoring member 110 and can connect the two components together. Delivery catheter 380 may then be withdrawn from the patient.

  53A-53H illustrate various mechanisms that can be used to connect the valve support 120 to the anchoring member 110 in the manner shown in FIGS. 52A-52D. For example, as shown in FIG. 53A, the valve support 120 has a circumferential ridge or detent 388 that engages in a groove 390 in the anchoring member 110 to prevent removal of the two components. , May be included in the vicinity of the downstream end thereof. Alternatively, the valve support 120 extends around the downstream end of the anchoring member 110, eg, around either the rib 114 or the downstream tip of the connector 116, as shown in FIGS. 53B-53C. A hook 392 formed at the downstream end of each column 122 may be included. For example, the hook 392 is configured to flex inwardly when engaging the inner surface of the rib 114 as the valve support 120 is advanced, as shown in FIG. It may be configured to elastically recoil to its outward configuration when expanded beyond the downstream end. A depth limit, such as a stub 394, optionally configured to engage a complementary feature, such as a step or ridge 396, on the anchor member 110 to prevent insertion of the valve support 120 beyond a predetermined depth. A feature may extend outward from the valve support 120.

  In a further embodiment, shown in FIGS. 53D-53F, the valve support 120 may have a coupling element 398 on its outer surface that is configured to slidably couple to the anchoring member 110. In the first configuration, the coupling element 398 comprises a loop 400 shown in FIG. 53E through which the vertical guide member 402 on the anchoring member 110 can slide. The anchoring member 110 may have a plurality of such guide members 402 extending upward from its downstream end at spaced locations around its circumference. A step 404 may be formed in the vicinity of the downstream end of each guide member 402 on which the loop 400 may slide so as to prevent the valve support 120 from sliding backward in the upstream direction. (FIG. 53D). In the alternative configuration shown in FIG. 53F, the guide member 402 has a vertical slot 406 into which a radially extending pin 408 on the valve support 120 can extend. The pin 408 may slide to the downstream end of the slot 406, where it can be pushed through the waist 411, preventing the pin 408 from sliding backward in the upstream direction.

  In a further embodiment, shown in FIGS. 53G-53H, the coupling elements 398 on the valve support 120 have ribs 114 that themselves perform a similar function as the guide member 402 (described with respect to FIGS. 53D-53F). Configured to be slidably received. As shown in FIG. 53G, the rib 114 is connected to the valve support 120 in a radially small configuration when the valve support 120 slides axially upward relative to the anchoring member 110. Helps to restrain 114. In the arrangement shown in FIGS. 53GG-53H, delivery of device 100 may not require the need for a separate sheath to constrain rib 114 during delivery. As shown in FIG. 53H, the valve support 120 may slide downstream relative to the anchoring member 110 until the ribs 114 are in their radially outward configuration. Similar to the guide member 402, each rib 114 can be pushed past the coupling element 398, but then near its downstream end, preventing the valve support 120 from sliding in the upstream direction. You may have the level | step difference 412 formed (FIG. 53H).

  54A-55C illustrate a delivery catheter 400 of the delivery system 40, according to additional aspects of the present technology. 54A is a cross-sectional side view of delivery system 40 for prosthetic heart valve device 100, and FIG. 54B is a partial cross-sectional side view of the distal portion of delivery system 40 shown in FIG. 54A. As shown in FIGS. 54A and 54B, the delivery catheter 400 includes a sheath 402 having an outer wall 403 and a closed distal protrusion 406 that defines a blind annular cavity 408. Inner wall 405 extends proximally to the proximal end of a catheter (not shown) and thus an axial lumen extending axially therethrough through which guidewire GW can be slidably positioned. A tubular catheter shaft 407 is formed that defines. The piston 412 is slidably disposed in the cavity 408 and has an O-ring 413 around its circumference to create a fluid seal with the wall of the cavity 408. Tubular piston shaft 414 extends proximally from piston 412 and is slidably mounted over catheter shaft 407. The piston shaft 414 is sized large relative to the catheter shaft 407 to define a fluid lumen 416 that communicates with the cavity 408. Device 26 is retained in its radially folded delivery configuration within cavity 408 with piston shaft 414 and catheter shaft 407 extending through the interior of valve support 120 (see FIGS. 55A-55C). Indicated). Preferably, device 100 is releasably connected to piston 412 by, for example, a pin (not shown) extending radially outward from piston shaft 414.

  The sheath 402 may have features that limit its progression. For example, a wire (not shown) may anchor the protective sheath to the handle on the proximal end of the catheter 400. The wire may be attached to an adjustable stop on the handle, allowing the length of piston travel to be adjusted. When fluid is injected into the cavity 408, the piston 412 will travel until this stop is reached. In this way, the progress of deployment can be controlled.

  A tapered feature may be advanced adjacent to the proximal end of the sheath 402 to facilitate retraction of the sheath 402 through the valve of the device 100 after deployment (see FIG. 56). Alternatively, the piston 412 may have a tapered or soft cushioning material attached directly to the rear of the piston 412 facing in the proximal direction. In this way, the proximal side of the piston will itself provide an atraumatic leading surface to facilitate retraction of the sheath 402 through the valve support 120.

  Features intended to control and smooth the deployment of device 100 can be incorporated. For example, a common problem during deployment of self-expanding stents is the tendency of the deployed device to “jump” or jump forward or backward as the final element exits the deployment device. The feature of preventing the sheath 402 from protruding forward by the enlarged skeleton of the device 100 can be important to prevent accidental damage to the ventricle or other tissue. Such features may incorporate stops or tethers in the deployment system that are designed to hold the position of the sheath 402 relative to the deployed device 100. For example, the proximal edge of the sheath 402 can be pulled out of the system through the deployed valve so as to prevent the piston from retracting from the sheath and accurately installing the tapered or cushioning features described above. Can be swaged slightly inward to facilitate Alternatively or additionally, a spring mechanism so that when the last feature of device 100 is withdrawn from sheath 402, the sheath is actively retracted slightly into the downstream end of newly deployed device 100. (Not shown) can be incorporated into the delivery system 40.

  The operation of delivery catheter 400 is illustrated in FIGS. 55A-55C. Delivery catheter 400 is positioned at the target valve site using one of the approaches described elsewhere herein. The delivery catheter 400 is particularly well suited for placement through the natural valve from the upstream direction. Catheter 400 is advanced until sheath 402 is positioned downstream of the natural annulus (FIG. 55A). Fluid can then be injected through the fluid lumen 416 and into the cavity 408 distal to the piston 412 (FIG. 55B). This drives the sheath 402 distally, releasing the device 100 from the cavity 408 (FIG. 55C). Delivery catheter 400 and device 100 may remain in a stationary longitudinal position relative to the native valve while device 100 is deployed, thereby increasing the accuracy of deployment. In addition, the device 100 may be deployed in a slowly controlled manner, avoiding sudden uncontrolled bounce of the device 100. Further, such hydraulic actuation allows the sheath 402 to be moved in incremental steps so that the device 100 is only partially deployed, and prior to full deployment, the operator assesses its position relative to the natural valve. Allows relocation if necessary.

  In one embodiment, the piston 412 can be hydraulically operated, but in another embodiment, the piston 412 can be operated by manual retraction of the piston shaft 414 or advancement of the sheath 402. Delivery catheter 400 may be equipped on its proximal end with a handle having a retraction mechanism coupled to piston shaft 414 and / or catheter shaft 407. Such a mechanism may use gears or pulleys to provide mechanical efficiency that reduces the force required to retract the piston or advance the sheath.

  A delivery catheter according to aspects of the present technology may be further configured to be reversible to allow the device 100 to be retracted back into the catheter 400 after full or partial deployment. One embodiment of such a catheter is illustrated in FIG. 56 and the delivery catheter 400 of FIGS. 54A-55C is fully or partially deployed therefrom and retracts the device 100 back into the sheath 402. To be adapted. The piston 412 has at least a first pulley 420 coupled thereto, while the distal protrusion 406 has at least a second pulley 422 coupled thereto. A plurality of additional pulleys 423 may also be provided at locations around the circumference of the piston 412 for additional mechanical assistance. A cable 424, which may comprise a single wire or suture, extends through the fluid lumen 416 and the cavity 408, around the first and second pulleys 420, 422 and any additional pulleys 423. Passes and is fixed to the piston 412. Device 100 is preferably releasably coupled to piston shaft 414 by a plurality of pins 426 extending radially from piston shaft 414 to engage device 100 near its downstream end 428. it can.

  To deploy the device 100, the delivery catheter 400 of FIG. 56 operates similarly as described above in connection with FIGS. 55A-55C, but in an additional embodiment, the downstream end 428 is a sheath. Before being completely released from 402, the operator can check the location of the device 100. Upon deployment, the upstream end 430 of the device 100 will expand toward its expanded configuration. An operator can use ultrasound, fluoroscopy, MRI, or other means to view the position and shape of the deployed device 100 in natural tissue. After positioning, the sheath 402 may be further advanced relative to the piston 412 to fully deploy the device 100 from the sheath 402, so that the downstream end 428 is fully expanded and the pin 426 is Disengage from device 100. In situations where the operator desires to re-enter into the sheath 402 and retrieve the device 100 for repositioning or other reasons, the cable 424 is pulled to move the piston 412 distally relative to the sheath 402. It is done. Pin 426 pulls device 100 back together with piston 412 into sheath 402, and device 100 is folded as it is pulled into sheath 402. The delivery catheter 400 may then be repositioned and the device redeployed.

  In one embodiment, the prosthetic heart valve device 100 may be specifically designed for a particular approach or delivery method to reach the mitral valve, or in another embodiment, the device 100 may be approached or delivered. It may be designed to be interchangeable between methods.

Additional Embodiments of Prosthetic Heart Valve Device, Delivery System, and Method FIGS. 57A-57E are isometric views of a prosthetic heart valve device 600 shown in an expanded configuration 602 and configured in accordance with additional embodiments of the present technology. It is. Prosthetic heart valve device 600 includes features that are generally similar to the features of prosthetic heart valve device 100 described above with reference to FIGS. For example, the prosthetic heart valve device 600 mechanically removes the valve support 120 from the valve support 120 configured to support the prosthetic valve 130 and the force exerted on the anchoring member 610 when implanted in a natural mitral valve. And a securing member 610 coupled to the valve support 120 in a segregating manner. However, in the embodiment shown in FIGS. 57A-57E, the downstream region 611 of the anchoring member 610 engages natural tissue above or downstream of the annulus to prevent movement of the device 600 in the upstream direction. As configured, the upstream region 612 of the anchoring member 610 is coupled to the valve support 120.

  57A and 57B illustrate an embodiment of the device 600 in which the anchoring member 610 includes a plurality of longitudinal ribs 614 that are coupled to the upstream end 121 of the valve support 120 and extend in a distal direction from the downstream. To do. As shown in FIG. 57A, the ribs 614 are downstream of the anchoring member 610 such that the downstream region 611 is outwardly flared to engage the sub-annular tissue below the mitral annulus. In the region 611, it can project radially outward from the longitudinal axis 101. FIG. 57B illustrates an embodiment of device 600 having an anchoring member 610 with an upwardly facing hole edge 617 in the downstream region. In this embodiment, the rib 614 is formed such that the downstream region is substantially skirted outward from the longitudinal axis 101, but the tip 615 of the rib 614 is reoriented and points in the upstream direction at the hole edge 617. Can do. The hole edge 617 may assist the anchoring member 610 in engaging sub-annular tissue and is configured to include a tissue engaging element (not shown) as described above with respect to the device 100. be able to. The anchoring member 610 can also be coupled to the valve support 120 at a desired location for positioning the valve support 120 and the prosthetic valve 130 within the natural valve. For example, FIG. 57C illustrates an embodiment of the device 600 that can couple the anchoring member 610 to the valve support 120 at a location downstream from the upstream end 121.

With both referring to FIG. 57C, the fixing member 610 may have a first cross-sectional dimension _{D C1} is smaller than the second cross-sectional dimension _{D C2} in the downstream region 611 in the upstream region 612. In addition, the valve support 120 is downstream of the anchoring member 610 so that when the device 600 is deployed, the downstream region 611 can be deformed inward without deforming the upstream portion of the valve support 120. Separated radially from region 611. In addition, while the anchoring member 610 can have a generally oval or D-shaped or other irregular shape such as that described above with respect to FIGS. Can be substantially cylindrical. In such an embodiment, the second cross-sectional dimension D _C2 may be larger than the corresponding cross-sectional dimension (eg, MVA1 or MVA2) of the natural mitral valve annulus (FIG. 5C).

  FIG. 57D illustrates yet another embodiment of the device 600 in the expanded configuration 602. As shown, the valve support 120 can include a flange 620 at the downstream end 123 of the valve support 120. The flange 620 can extend radially outward from the longitudinal axis 101 at the downstream end 123 to radially engage the sub-annular tissue. The anchoring member 610 can include a plurality of ribs 614 that are coupled to the upstream end 121 of the valve support 120 and extend radially outward in a downstream direction so as to adhere to the outer peripheral edge 622 of the flange 620. . The anchoring member 610 can be configured to engage subannular tissue such as the inwardly facing surface of the leaflet. In this embodiment, the rib 614 causes the deformation of the anchoring member 610 between the connection in the upstream region 612 and the connection to the flange 620 in the lower region 611 to substantially cause the valve support 120 to which the artificial valve is connected. It can be flexible so as not to deform.

  FIG. 57E is a schematic cross-sectional view of the prosthetic heart valve device 600 of FIG. 57A implanted in a natural mitral valve MV, according to an embodiment of the present technology. As shown, the skirted downstream region 611 of the anchoring member 610 can engage the sub-annular tissue, such as the inward surface of the leaflet LF, the sub-annular surface, and the like. The rib 614 can incorporate a tissue engaging element 170 over the rib tip 615 to penetrate and / or partially penetrate tissue. Further, the anchoring member 610 seals radially outward with respect to the tissue (not shown) to prevent movement of the device 600 in the upstream or downstream direction and / or between the tissue and the device 600. Can be expanded to prevent paravalvular leakage in between. Thus, the device 600 can incorporate one or more sealing members 140 as described above with respect to the device 100. In addition, the device 600 can also include an atrial dilator or atrial support 410 (shown in dotted lines), as described above with respect to the device 100. The atrial holder, when present, engages tissue above the annulus AN, such as the supra-annular surface or any other tissue in the left atrium LA, and moves downstream of the device (eg, during atrial systole). Can be configured to block.

  58A-58D are cross-sectional views of the heart illustrating a method for delivering a prosthetic heart valve device 600 to a native mitral valve MV in the heart using a transapical approach, according to another embodiment of the present technology. Referring to FIG. 58A, delivery catheter 18 is advanced through a guiding catheter (not shown) that enters the left ventricle LV of the heart through a puncture in the left ventricular wall at or near the apex and by purse string suture Sealed. Alternatively, delivery catheter 18 may be placed directly through a transapical incision sealed with a purse string suture without a guiding catheter. The sheath 20 containing the folded devices 600, 606 (shown in FIG. 58B) is advanced through the mitral annulus AN between the natural leaflets LF, as shown in FIG. 58A. Referring to FIGS. 58B-58D together, the sheath 20 is pulled proximally to allow the device 600 to expand to the expanded and / or deployed configuration 602, 604 (FIGS. 58C and 58D).

  The sheath 20 can be retracted and the device 600 can be expanded, but the delivery system can allow the operator to control the placement of the device 600 while in the expanded configuration 602 (FIGS. 58C and 58D). Can remain connected to 600 (eg, a system eyelet not shown is connected to a device eyelet not shown). For example, when the sheath 20 is disengaged from the device 600, the upstream region 612 of the anchoring member 610 remains folded within the sheath, preventing the anchoring member 610 from fully expanding (FIG. 58C). ). During this stage of delivery, the position of device 600 within the mitral valve region can be adjusted or changed. After the device 600 is located at the target site, the sheath 20 can be completely removed from the device 600 so that the anchoring member 610 of the device 600 engages with sub-annular tissue, such as the leaflet LF, and as desired. Can be expanded outward in the downstream region 611 to hold the device 600 at the target location. A puller wire (not shown) may be retracted proximally to release the device 600 from the delivery system, the delivery system is removed, and the device is fully implanted in the mitral valve MV in the deployment configuration 104. Make it possible. Alternatively, device 600 is expanded upstream or downstream of the desired target location and then retracted or pushed into the target location downstream or upstream, respectively, before releasing device 600 from the delivery system. Also good.

  59A-59C are isometric views of a prosthetic heart valve device 700 shown in an expanded configuration 702, and FIG. 59D shows a prosthetic heart implanted in a natural mitral valve configured in accordance with a further embodiment of the present technology. 2 is a schematic cross-sectional view of a valve device 700. FIG. Prosthetic heart valve device 700 includes features that are generally similar to the features of prosthetic heart valve devices 100 and 600 described above with reference to FIGS. For example, the prosthetic heart valve device 700 includes a valve support 120 configured to support the prosthetic valve 130 and a valve support from forces exerted on the first anchoring member 610 when implanted in a natural mitral valve. And a first anchoring member 610 coupled to the valve support 120 in a mechanically isolating manner. In particular, the upstream region 612 of the first anchoring member 610 is coupled to the valve support 120 and the downstream region 611 of the first anchoring member 610 faces outward to prevent movement of the device 600 in the upstream direction. Configured to expand and engage natural tissue above or downstream of the annulus. However, in the embodiment shown in FIGS. 59A-59D, the device 700 also has a downstream region 711 coupled to the valve support 120 and an upstream region 712 extending radially outward in the upstream direction. 2 fixing members 710 are also included. Thus, the device 700 includes both first and second anchoring members 610 and 710 for engaging tissue above or below the mitral valve annulus.

With both referring to FIG. 59a to 59d, the first fixing member 610 may have a first cross-sectional dimension _{D C1} is smaller than the second cross-sectional dimension _{D C2} in the downstream region 611 in the upstream region 612. The second fixing member 710 may have a third cross-sectional dimension _{D C3} is larger than the fourth cross-sectional dimension _{D C4} in the downstream region 711 in the upstream region 712. In some embodiments, the third cross-sectional dimension _DC3 is greater than the second cross-sectional dimension _DC2 so that the second anchoring member 710 can be partially surrounded by the first anchoring member 610. Small (FIG. 59A). In such an embodiment, the upstream region 712 applies a radially outward pressure against the inner wall (not shown) of the first anchoring member 610 to provide a first to tissue above or below the annulus. The fixing member 610 can be further supported. In another embodiment shown in FIG. 59B, the third cross-sectional dimension _{D C3,} as the first and second fastening members 610 and 710 intersect at skirt wide junction 740, a second cross-sectional dimension _{D C2} It can be substantially the same. In one embodiment, the first and second anchoring members 610 and 710 can be coupled at the wide joint 740, while in other embodiments, the first and second anchoring members 610 and 710 are coupled. Not. FIG. 59C shows another embodiment of the device 700 where the downstream region 615 of the first anchoring member 610 is separated from the upstream region 713 of the second anchoring member 710 by a gap 750. In one embodiment, the device 700 shown in FIG. 59C allows the first anchoring member 610 to be on the annulus or other cardiac tissue upstream of the annulus, such that the annulus is retained or captured within the gap 750. And can be implanted in a natural heart valve so that the second anchoring member 710 can engage sub-annular tissue or other heart tissue downstream of the annulus.

In a further embodiment, illustrated in FIG. 59D, the third cross-sectional dimension _DC3 is such that the second cross-sectional dimension _DC3 allows the second anchoring member 710 to partially surround the first anchoring member 610. It is larger than the dimension _DC2 . In such an embodiment, the downstream region 611 of the first anchoring member 610 applies a radially outward pressure against the inner wall 741 of the second anchoring member 710, and the tissue above or below the annulus AN. The fixing of the second fixing member 710 to the hood can be further supported.

  In addition, the valve support 120 is a valve that supports the prosthetic valve 130 without the downstream region 611 and / or the upstream region 712 substantially deforming the valve support 120 when the device 700 is deployed. Separating radially from the downstream region 611 of the first securing member 610 and the upstream region 712 of the second securing member 710 so that the supporting region 734 of the support 120 can be deformed inward without being deformed. can do. In addition, while the first and second anchoring members 610, 710 can have a generally oval or D-shape, or other irregular shapes such as those described above with respect to FIGS. The valve support 120 may be substantially cylindrical in shape. Additional features such as sealing membrane 140 and tissue engaging element 170 as described above with respect to device 100 may also be incorporated on device 700.

  60A-60B are cross-sectional side views of the distal end of a delivery catheter 18 for delivering the prosthetic heart valve device 700 of FIG. 59C to a natural mitral valve in the heart, according to another embodiment of the present technology. . As shown in FIGS. 60A-60B, the prosthetic heart valve device 700 is folded into a delivery configuration 706 and held within the two-part delivery sheath 70 at the distal end of the catheter 18 (FIG. 60A). Upon delivery of the distal end of the catheter 18 to a desired location at or near the natural mitral valve, the upper portion 72 is retracted distally and / or the lower portion 74 is retracted proximally ( 60A, whereby the device 700 can be released from the two-part sheath 70 by separating the sheath and exposing the folded device 700 from within the sheath 70. In one embodiment, the device 700 can self-expand to its expanded configuration 702 after the sheath 70 is retracted (FIG. 60B). As illustrated in FIG. 60B, when the sheath 70 is retracted in both the proximal and distal directions, the first and second anchoring members 610, 710 face outward to engage the natural tissue. Can self-expand. When using the balloon 300 to expand the support valve 120, the balloon 300 can be inflated to fully expand the device 700.

  FIG. 61 illustrates a prosthetic heart valve device 800 configured in accordance with another embodiment of the present technology. FIG. 61 is a side view of a device 800 that includes features that are generally similar to the features of the prosthetic heart valve devices 100, 600, 700 described above with reference to FIGS. For example, device 800 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior to which a valve (not shown) can be coupled. The device also includes first and second anchor members 810 and 850. The first securing member 810 has a first skirted upstream portion 812 and a first downstream portion 811 coupled to the outside or outer surface 127 of the valve support 120. The first skirted upstream portion 812 can be mechanically isolated from the valve support 120. Additionally, the first skirted upstream portion 812 can be configured to engage the natural mitral valve supra-annular tissue. The second anchoring member 850 has a second skirted upstream portion 852 to at least partially surround the first anchoring member 810 and to engage the sub-annular tissue of the natural mitral valve. It can be constituted as follows. The second anchoring member 850 also has a second downstream portion 851 that is coupled to the outer surface 127 of the valve support 120 in a manner that mechanically isolates the valve support 120 from at least the second upstream portion 852. You can also.

As shown in FIG. 61, the first anchoring member 810 can have a plurality of first longitudinal ribs 814 and the second anchoring member 850 has a plurality of second longitudinal ribs 854. be able to. In one embodiment, each of the individual first ribs 814 has a respective second height such that the first anchoring member 810 has a height H _AM1 that is greater than the height H _{AM2 of} the second anchoring member 850. Longer than each of the ribs 854. Accordingly, the height _HAM2 can be selected to orient the second anchoring member 850 to engage the sub-annular tissue while extending from the left ventricle through the mitral valve. The height H _AM1 can be selected to orient the first anchoring member 810 to engage the supra-annular tissue in the left atrium.

  FIG. 61 illustrates one embodiment of a device 800 that can include a lower ring 808 on which the ribs 814, 854 can be interconnected. The lower ring 808 can allow the ribs 814, 854 to expand radially outward away from the valve support 120 at the upstream portions 812, 852. The device 800 can also include a first upper ring member 816 that is coupled to a plurality of first longitudinal ribs 814. The first upper ring member 816 can be shaped and / or patterned to have a downwardly oriented peripheral edge 818 for engaging the supra-annular tissue. The device can further include a second upper ring member 856 coupled to the plurality of second longitudinal ribs 854. The second upper ring member 856 can be shaped and / or patterned to have an upwardly oriented peripheral edge 858 for engaging sub-annular tissue.

  62A-62C are partial cross-sectional side views of the distal end of the delivery system 10 illustrating the delivery of the prosthetic heart valve device 800 of FIG. 61 at the mitral valve MV, according to another embodiment of the present technology. The device 800 can be held in the folded configuration 806 within the sheath 20 of the delivery system (FIG. 62A). When the distal end of the delivery system engages the target location, the sheath 20 can be retracted proximally from the device 800, thereby releasing the features of the device 800 to expand into the expanded configuration 102 (FIG. 62B-62C). As shown in FIG. 62B, the second anchoring member 850 can be initially released from the retracting sheath 20, and the upwardly oriented peripheral edge 858 of the second upper ring member 856 is in the sub-annular tissue. It can be positioned to engage. The sheath 20 disengages the first anchoring member 810 from the delivery system 10 and / or until the peripheral edge 858 of the second anchoring member 850 is moved into place to engage the sub-annular tissue. Or it can prevent moving outside the sheath 20. Referring to FIG. 62C, the plunger 11 can engage the first anchoring member 810 (as indicated by the downward arrow in FIG. 62B) and / or the sheath 20 can be the first anchoring member 810. (As indicated by the upward arrow in FIG. 62C) can be disengaged / retracted, thereby allowing the second anchoring member 850 to move radially outward to the expanded configuration 802. The downwardly oriented peripheral edge 818 of the first upper ring member 816 can be positioned to engage the supraannular tissue (FIG. 62C). Once deployed, the rings 816, 856 can pinch the mitral valve annulus AN and prevent movement of the device 800 in both upstream and downstream directions.

  FIG. 63 is an isometric side view of a prosthetic heart valve device 900 according to a further embodiment of the present technology. Device 900 includes features that are generally similar to the features of prosthetic heart valve devices 100, 600, 700, and 800 described above with reference to FIGS. For example, device 900 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior to which a valve (not shown) can be coupled. The device 900 includes an anchoring member 910 having a skirted upstream portion 912 and a downstream portion 911 that is coupled to the valve support 120. However, the device 900 is also distributed over the upper and lower rings 950, 952 and the circumference 980 of the anchor member 910 and is configured to couple the upper ring 950 to the lower ring 952. Annulus engagement element 970. The flexible annulus engagement element 970 has an open portion outwardly from the device 900 so that the natural annulus AN can be engaged in the recess 971 of the annulus engagement element 970. It can have a shape such as a C-shape or U-shape that is oriented. The annulus engaging element 970 can also include tips 972, 973 for engaging and potentially puncturing the annulus or subannular tissue, respectively. The annulus engaging element 970 may be suitably flexible so that when the device 900 is deployed, the tips 972, 973 are bent together to secure the device 900 to the annulus AN.

64A-64B illustrate a method for deploying device 900 in a natural mitral annulus. Referring to FIGS. 63 and 64A-64B together, the annulus engagement element 970 can be generally relaxed or have a wide recess 971 in the open state 903. Accordingly, the upper ring 950 can rest above the lower ring 952 at the first distance _DR1 when the element 970 is in the open state 903. The device 900 can also include a plurality of puller wires 974 that are slidably engaged with the upper ring 950 (eg, through holes 975) and secured to the lower ring 952. When wire 974 is pulled upward or upstream, lower ring 952 moves upward / upstream toward upper ring 950. As the lower ring 952 approaches the upper ring 950, the annulus engaging element 970 can bend so that the tips 972, 973 are brought together and / or engage or puncture the annulus tissue (FIG. 64B). Therefore, when the device 900 is in an open condition 904, upper ring 950 can be held by the pull wires 974 at the second distance _{D R2} in above the lower ring 952, second distance _{D R2} is a It is smaller than the distance _{DR1 of} 1.

  FIGS. 64C-64D show an alternative arrangement of tension wires 974 where wire 974 is secured to upper ring 950 and slidably engaged with lower ring 952 (eg, through hole 976). The puller wire 974 is also slidably engaged with the upper ring 950 (eg, through the hole 975) so that the puller wire can be pulled upward to bring the rings 950, 952 closer together in the deployed state 904. You can also.

FIG. 65A is an isometric side view of a prosthetic heart valve device 1000 in accordance with a further embodiment of the present technology. Device 1000 includes features that are generally similar to the features of prosthetic heart valve devices 100, 600, 700, 800, and 900 described above with reference to FIGS. For example, the device 1000 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior 134 to which the valve 130 can be coupled. However, the device 1000 includes an inflatable anchoring member 1010 that is coupled to and at least partially surrounds the valve support 120. The inflatable anchoring member 1010 can be configured to expand / expand upon deployment and engage natural tissue at a desired target location. As shown in FIG. 65A, the inflatable anchor member 1010 can be a solution (eg, saline or other liquid) or gas (eg, helium, CO ₂ , or other gas), etc., after implantation of the device 1000. There may be one or more fillable chambers 1014 for receiving a filling material. In other embodiments, the fillable chamber 1014 can be filled with a hardened material (eg, epoxy, cement, or other resin).

  In one embodiment, the fillable chamber 1014 and / or anchoring member 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other foamable polymer or biocompatible material. The fillable chamber 1014 can have a predetermined shape such that when the fillable chamber 1014 is inflated, it forms a fixation element 1015 for engaging the natural anatomy. For example, the fixation element 1015 can include an annulus flange 1016 for engaging the surface of the annulus AN in the left atrium LA. Element 1015 may also include an annulus flange 1018 for engaging the annulus tissue and / or an arm 1020 for engaging the leaflet LF (eg, behind the leaflet). Thus, anchoring while mechanically isolating the valve support 120 from the diastolic and systolic distortion forces generated in the heart, particularly the radial force exerted on the device 1000 at or near the native mitral valve. The chamber 1014 can be incorporated or shaped such that the member 1010 engages other tissue at or near the supra-annular tissue, sub-annular tissue, valve leaflets, or mitral valve MV. For example, after deployment, the inflatable anchoring member 1010 absorbs pulsatile loads and other forces generated against the device 1000 such that deformation of the anchoring member 1010 does not substantially deform the valve support 120. Can do.

  65B is a partial cross-sectional side view of the distal end of the delivery system 10 suitable for delivery of the prosthetic heart valve device 1000 of FIG. 65A, according to another embodiment of the present technology. As shown in FIG. 65B, the delivery system 10 can include a delivery catheter 18 configured to hold the device 1000 in a folded configuration 1006. In the folded configuration 1006, the inflatable securing member 1010 is contracted. The delivery system 10 can also include a filling tube 90 suitable for delivering a filling material when the device 1000 is in place and ready for deployment. Referring to FIGS. 65A-65B together, in one embodiment, anchoring element 1015 is aligned with natural tissue features prior to fully expanding and / or expanding anchoring member 1010 to keep device 1000 in place at the target location. The inflatable anchor member 1010 can be partially filled with a filling material so that the position of the device 1000 at the implantation site can be adjusted.

  66A-66D are cross-sectional views of a prosthetic heart valve device 1100 having a fillable chamber 1114 according to additional embodiments of the present technology. Similar to device 1000 discussed with respect to FIGS. 65A-65B, device 1100 includes features such as valve support 120 having an interior 134 to which valve 130 is coupled and when implanted in a natural mitral valve. An expandable anchoring member 1110 is included that is coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the anchoring member 1110. The anchor member 1110 is configured to be a valve support such that the upstream region 1112 of the anchor member 1110 is configured to engage natural tissue above or downstream of the annulus to prevent movement of the device 1100 in the upstream direction. 120 can be connected. In the embodiment shown in FIGS. 66A-66D, device 1100 also expands and / or expands in the outward direction to support outward expansion of anchoring member 1100 (FIGS. 66A, 66C-66D), or One or more fillable chambers 1114 may also be included that are configured to engage natural tissue (FIG. 66B). In one embodiment, the fillable chamber 1114 and / or anchoring member 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other foamable polymer or biocompatible material. When the fillable chamber 1114 is inflated, it engages the natural anatomy (as shown in FIG. 66B) or as shown in FIGS. 66A, 66C, and 66D. The fillable chamber 1114 can have a predetermined shape so as to form a securing element for engaging the.

Referring to FIG. 66A, the fillable chamber 1114 can be a chamber 1114 that is created with a space between the valve support 120 and the anchoring member 1110. After expansion of the device 1100, the fillable chamber 1114 can be filled with a filling material, such as a solution (eg, saline or other liquid) or a gas (eg, helium, CO ₂ , or other gas). . In other embodiments, the fillable chamber 1114 can be filled with a hardened material (eg, epoxy, cement, or other resin). In other embodiments, the fillable chamber 1114 is a ring-shaped chamber 1150 that is coupled to the outer surface 1142 (FIG. 66B) of the anchoring member 1110, to the inner surface 1141 of the anchoring member 1110, or to the outer surface 127 of the support valve 120. Etc., which may be separate components of the device 1100. In FIGS. 66C-66D, for example, the ring-shaped chamber 1150 can provide additional support to the anchoring member 1110 such that inward deformation is countered by the presence of the ring-shaped chamber 1150. In addition, as shown in FIG. 66D, the fillable chamber 114 can be a ring-shaped chamber 1150 that deforms the anchoring member 1110 in an outward direction relative to the natural tissue.

According to another aspect of the present technology, FIGS. 67A-67B illustrate another embodiment of a prosthetic heart valve device 1200. Referring to FIGS. 67A-67B together, the device 1200 includes a radially expandable anchoring member 1210 configured to engage natural tissue above or downstream of the annulus and an interior 1234 of the anchoring member 1210. A support valve 120 and / or a prosthetic valve 130 may be included. The anchoring member 1210 has a first longitudinal length L _L1 on the side 1222 facing the rear apex of the anchoring member 1210 and a second longitudinal length L on the side 1224 facing the front apex of the anchoring member 1210. Can have _L2 . As shown in FIG. 67A, the first length L _L1 is greater than the second length L _L2 so that the occlusion of the left ventricular outflow tract (LVOT) is limited. Thus, in one embodiment, the posterior apical side 1222 provides suitable fixation and support of the anchoring member 1210 by engaging the thicker ventricular wall and tissue on the posterior apical side of the mitral valve. Can do. At the same time, the shorter anterior leaflet side 1224 of the anchoring member 1210 is sufficiently sealed and conformable to engage sub-annular tissue aligned with the anterior leaflet and / or the anterior leaflet of the native valve. be able to.

  Optionally, device 1200 can also include one or more stabilizing elements, such as arms 1250, that are coupled to anchoring member 1210 to engage the leaflets and / or the sub-annular surface. In FIG. 67A, the arm 1250 can be coupled to the downstream end 1223 of the anchoring member 1210 at the side 1222 facing the posterior apex of the anchoring member 1210 and can be configured to extend behind the posterior apex. In one embodiment, the arm 1250 can be configured to sandwich a posterior leaflet between the arm 1250 and the anchoring member 1210.

  In FIG. 67B, device 1200 includes first and second arms (identified individually as 1250a and 1250b) that are coupled to anchoring member 1210 to engage the leaflets and / or the sub-annular surface. Can be included. For example, the first arm 1250a can be connected to the downstream end 1223 at the extension 1251a on the side 1224 facing the front apex of the anchoring member 1210, and configured to extend further behind the front apex. Can do. The second arm 1250b can be configured to connect to the downstream end 1223 of the side 1222 facing the rear leaflet of the securing member 1210 at the extension 1251b and extend behind the leaflet. In the illustrated embodiment, the extensions 1251a and 1251b vary relative to each other and can be selected based on the anatomy of the target tissue. In other embodiments not shown, the arm 1250 and / or anchoring member 1210 may be a tissue anchor as described above with respect to the device 100 for further positioning and stabilization of the device 1200 at the desired target location. It can contain a combination element. Those skilled in the art will also understand that the valve support 120 may also be uneven or have sides with different lengths so that the valve support does not substantially occlude the left ventricular outflow tract (LVOT). You will recognize that you can.

  68A-68B are side views of a prosthetic heart valve device 1300 shown in an expanded configuration 1302 and configured in accordance with additional embodiments of the present technology. The prosthetic heart valve device 1300 includes features that are generally similar to the features of the prosthetic heart valve device 100 described above with reference to FIGS. For example, the prosthetic heart valve device 1300 machine the valve support 120 from the force exerted on the anchoring member 110 when implanted in the natural mitral valve and the valve support 120 configured to support the prosthetic valve 130. And a securing member 110 coupled to the valve support 120 in a segregated manner. However, in the embodiment shown in FIGS. 68A-68B, device 1300 is also configured to adjust or maintain the desired position of device 1300 in or near the natural mitral valve (eg, away from the LVOT). Also includes a positioning element 1350. The locating element 1350 is coupled to the downstream portion 111 of the anchoring member 110, the upstream portion 112 of the anchoring member 110, or the valve support 120 (as shown in FIGS. 68A-68B) at the element connection point 1352 to a desired location. Can extend outwardly from the element connection point 1352 to engage the ventricular tissue. In one embodiment, the positioning element 1350 can extend outwardly from the device 1300 in a direction generally transverse to the longitudinal axis 101. In other embodiments not shown, the locating element 1350 can extend outward from the device 1300 at an obtuse or acute angle relative to the longitudinal axis 101 to engage the ventricular tissue at a desired location. .

In the embodiment shown in FIG. 68A, the positioning element 1350 can include a positioning arm 1354 and a tissue engaging portion 1356 coupled to the distal arm end 1358 of the positioning arm 1354. Both the locating arm 1354 and the tissue engaging portion 1356 are separated from an element connection point 1352 on the device 1300 (eg, such that the distal end 1360 of the locating element 1350 can engage ventricular tissue such as a ventricular wall (eg, , from the fixing member 110) can extend to the desired positioning distance _{D P1.} In some embodiments, the positioning distance D _P1 is such that the positioning element 1350 extends to a distance between the implant device 1300 and the ventricular tissue after the positioning element 1350 engages the ventricular tissue. It can be selected to be greater than the distance to the ventricular tissue. In this way, the device 1300 can be positioned, aligned and maintained in alternative locations within or near the mitral valve.

  Tissue engaging portion 1356 contacts ventricular tissue or other tissue (eg, annulus tissue, leaflet tissue, etc.) in an atraumatic manner such that tissue engaging portion 1356 does not penetrate or puncture the tissue. It can be constituted as follows. In one embodiment, the tissue engaging portion 1356 can be elastic and / or formed of a shape memory material (eg, nitinol) that can be partially deformed when engaged with tissue. For example, the tissue engaging portion 1356 is generated by ventricular tissue (eg, the ventricular wall), eg, during systole, without conveying the movement or changing the desired position of the device 1300 relative to the natural mitral valve. It can be configured to absorb force. In other embodiments, the distal end 1360 of the locating element 1350 can have other shapes or configurations that penetrate the ventricular tissue. The device 1300 can include one or more positioning elements 1350 disposed around the device 1300 to position and / or maintain the desired position of the device 1300 relative to the natural anatomy. For example, it may be desirable to increase the distance between the device 1300 and the left ventricular outflow tract (LVOT) so that the positioning element 1350 engages the ventricular tissue to a selected distance away from the LVOT. Can be configured to push or prompt.

In the embodiment shown in FIG. 68B, the positioning element 1350 can include a looped tissue engaging portion 1358 that is coupled to the device 1300 at a connection point 1352. The looped tissue engaging portion 1358 is spaced from an element connection point 1352 on the device 1300 so that the distal end 1360 of the looped tissue engaging portion 1358 can engage ventricular tissue, such as a ventricular wall ( For example, it can extend to a desired positioning distance D _{P1 (} from the anchoring member 110). The looped tissue engaging portion 1358 may be a radially contracting force or ventricle (eg, in the left ventricle) so that it is not transmitted to the position of the device 1300 relative to the natural heart valve or can be repositioned. It can be configured to absorb other forces generated and transmitted by the tissue. Thus, the device 1300 can be positioned, aligned and maintained in alternative locations within or near the mitral valve.

  In another embodiment not shown, a positioning structure separate from the prosthetic heart valve device 100 can be implanted or otherwise positioned within the left ventricle (eg, at or near the LVOT). , Can be configured to engage a portion of the device 100 such as the anchoring member 110. Accordingly, such a positioning structure can be provided to prevent the device 100 from occluding or partially occluding the LVOT. In one embodiment, not shown, the positioning structure expands to engage the ventricular wall, leaving the LVOT unobstructed to allow blood to flow freely from the left ventricle through the aortic valve. It can be a stent-like cylinder or a cage. In one example, the positioning structure is inserted through the aorta and aortic valve into the left ventricle or through the apex or left atrium via the same delivery catheter used to deliver and implant the device 100. It can be delivered by a catheter.

  69A-69E are cross-sectional and side views of a prosthetic heart valve device 1400 shown in an expanded configuration 1402 and configured in accordance with additional embodiments of the present technology. The prosthetic heart valve device 1400 includes features that are generally similar to the features of the prosthetic heart valve devices 100, 600 described above with reference to FIGS. For example, the prosthetic heart valve device 1400 machine the valve support 120 from the force exerted on the anchoring member 110 when implanted in the natural mitral valve and the valve support 120 configured to support the prosthetic valve 130. And an anchoring member 110 or 610 coupled to the valve support 120 in a segregating manner. However, in the embodiment shown in FIGS. 69A-69E, the device 1400 is also coupled to a tissue engaging portion of the anchoring member 110 to add to engage natural tissue at or near the heart valve annulus. Also included is an expandable tissue engaging ring 1450 that is configured to provide a general contact surface.

  In one embodiment shown in FIGS. 69A-69B, the expandable tissue engaging ring 1450 connects to the upstream perimeter 113 of the anchoring member 110 and provides a tissue engaging surface 1452 facing outwardly relative to the device 1400. Can have. In some embodiments, the tissue engaging surface 1452 can have a tissue engaging element 170 for engaging and / or piercing tissue. In another embodiment shown in FIG. 69C, the expandable tissue engaging ring 1450 can be coupled to the downstream perimeter 115 of the anchoring member 1410 and faces outwardly with respect to the device 1400. 1452. In another embodiment shown in FIG. 69D, expandable tissue engagement ring 1450 is configured to promote tissue ingrowth, thrombus, and / or provides a seal between anchoring member 110 and tissue. A plurality of fibrous elements 1454 (eg, fiber elements) may be included that may be configured as such. In various arrangements, the expandable tissue engagement ring 1450 can expand and contract between various deployment and delivery configurations.

  FIG. 69E shows another embodiment of a prosthetic heart valve device 1400 having an expandable tissue engagement ring 1450. In this embodiment, the device 1400 can have a valve support 120 that is coupled to the first anchoring member 110 and the second anchoring member. In one embodiment, the first anchoring member 110 is coupled to the valve support 120 at the downstream end 123 and can be expanded outward and upstream. The second securing member 1410 can be coupled to the valve support 120 at the upstream end 121 and can be expanded outward and downstream. An expandable tissue engaging ring 1450 is coupled to the distal portion of the first and second anchoring members 110, 1410 to engage tissue at or near the annulus AN or leaflet LF. There may be a tissue engaging surface 1452 facing in an outward direction relative to the device 1500. In certain examples, the expandable tissue engaging ring 1450 can have a first end 1460 that is coupled to an upstream end 1461 of the first anchoring member 110. The expandable tissue engaging ring 1450 can also have a second end 1470 that is coupled to the downstream end 1471 of the second anchoring member 1410. The tissue engaging surface 1452 may also include a tissue engaging element 170 for engaging and / or puncturing tissue at the target location.

  Referring to FIGS. 69A-69E together, the outward radial force of the expandable tissue engagement ring 1450 against the tissue supported by the anchoring members 110 and / or 1410 prevents the device 1400 from moving upstream. can do. In addition, the expandable tissue engagement ring 1450 may provide a diminishing radial compressive force exerted from the heart valve tissue to the device 1400 with at least the portion of the anchoring member 110 and / or 1410 that is disconnected from the valve support 120. Thus, the valve support 120 and the valve 130 can be effectively mechanically isolated.

  FIG. 70 is a cross-sectional side view of another prosthetic heart valve device 1500 configured in accordance with an embodiment of the present technology. The device 1500 may also include features as described above, including the valve support 120 and the prosthetic valve 130 held within the valve support 120. The device 1500 can also include a plurality of anchoring members (identified individually as 110a-c). The anchoring members 110a-c are coupled to the valve support 120 at their respective downstream perimeters 115a-c so that each upstream perimeter 113a-c can engage the heart tissue at a variable target location in the natural valve. It can be separated by a gap 1515. Optionally, device 1500 can also include an expandable tissue engagement ring 1450 (FIGS. 69A-D), such as one having a tissue engagement feature 170 for further engagement with tissue in a native valve. In one embodiment, the expandable tissue engaging ring 1450 can be coupled to the upstream perimeter of more than one anchoring member (eg, the upstream perimeters 113b and 113c of anchoring members 110b and 110c). However, in other arrangements, the device 1500 will not have an expandable tissue engaging ring 1450.

  71 is a cross-sectional side view of yet another prosthetic heart valve device 1600 configured in accordance with an embodiment of the present technology. The device 1600 can also include features as described above, including the valve support 120 and the prosthetic valve 130 held within the valve support 120. Device 1500 can also include an anchoring member 110. However, the device 1600 can also include an expandable retainer 1610 for further engagement with tissue at or near the native annulus. In one embodiment, the retainer 1610 may be an extension of the upstream end 121 of the valve support 120, but in another embodiment, the retainer 1610 is a separate piece coupled to the upstream end 121 of the valve support. Expandable features can be included. In some arrangements, the retainer 1610 may be mechanically isolated from the valve support 120 such that forces generated in the natural valve are absorbed by the retainer 1610 or otherwise transmitted. it can. In this way, the retainer 1610 may be deformed by the radial force exerted on the retainer 1610, while the valve support remains substantially undeformed.

  In one embodiment, as shown, the anchoring member 110 can be configured to engage the retainer 1610, but in other embodiments, the anchoring member 110 can be attached to the retainer 1610. It can be positioned differently to contact different tissues. For example, the anchoring member 110 may extend outside the radius (not shown) of the retainer so as to contact the sub-annular tissue. Additional details and embodiments regarding the structure, delivery, and attachment of the retainer 1610 suitable for use with the prosthetic heart valve devices disclosed herein are incorporated herein by reference in their entirety. , International PCT Patent Application No. PCT / US2012 / 61215 (Attorney Docket No. 82829-8005WO00) entitled “DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT”, filed Oct. 19, 2012 .

  FIG. 72 is an isometric view of a prosthetic heart valve device 1700 according to another embodiment of the present technology. The device 1700 can include a securing member 110, a valve support 120 positioned radially within at least a portion of the securing member 110, and a prosthetic valve 130 held within the valve support 120. The device 1700 can further include a first sealing member portion 140a coupled to the inner wall of the anchoring member 110 and a second sealing member portion 140b coupled to the inner wall of the valve support 120. In other embodiments, the first sealing member portion 140a can be coupled to the outer wall of the anchoring member 110 and / or the second sealing member portion 140b can be coupled to the outer wall of the valve support 120. it can. The first and second sealing member portions 140a and 140b can be an integral part of a single sealing member, or the first and second sealing member portions 140a and 140b can be fixed members 110 and valve supports. It can be a separate sealing member that is independently attached to 120. Both the first and second sealing member portions 140a and 140b may prevent or prevent blood from flowing outside the valve support 120 when blood flows from the atrium to the ventricle, or vice versa. Anyway, a sealing barrier will be formed between the valve support 120 and the anchoring member 110. Similar to some embodiments described above, the upstream portion 121 of the valve support 120 is spaced radially inward from the anchoring member 110 and the downstream portion 123 of the valve support 120 is spaced from the anchoring member 110. Connected.

  73 is a side view of a prosthetic heart valve device 1700 and FIG. 74 is an isometric view of the prosthetic heart valve device 1700. The anchoring member 110 includes an anchoring portion 1710 configured to securely anchor the anchoring member 110 to tissue in a natural heart valve and an integrated region 1720 configured to integrate the anchoring member 110 with the valve support 120. And a side portion 1730 between the fixed portion 1710 and the integrated region 1720. Fixed portion 1710, integrated region 1720, and side 1730 can be formed by a plurality of structural elements 1711 that can extend from fixed portion 1710 to integrated region 1720. The integrated region 1720 and the side region 1730 can collectively or individually define a connection structure that positions and controls the fixed portion 1710 relative to the valve support 120. The structural elements 1711 can be shaped and connected to form a diamond or other structural configuration that provides the desired strength and flexure. The structural element 1711 can be a post or other structural feature formed from metal, polymer, or other suitable material that can be self-expanding or can be expanded by a balloon or other mechanical expander.

  Some embodiments of the anchoring portion 1710 are generally cylindrical with an outwardly engaging surface 1712 that can be a large generally cylindrical surface for engaging tissue at or near the annulus of the natural valve. It can be a retaining ring. For example, the outer surface of the securing portion 1710 can extend in a direction PP that is at least substantially parallel to the longitudinal axis LL, or the securing portion 1710 can taper all or part of the securing ring in the upstream direction. Thus, it can be inclined and converged from the side portion 1730 toward the longitudinal axis LL. For example, the fixed portion 1710 can be inclined inward (arrow I) in the upstream direction toward the longitudinal axis LL at an angle of 0 to −30 ° with respect to the longitudinal axis LL. In other embodiments, the fixed portion 1710 can be tilted outward (arrow O) from the longitudinal axis LL by an angle of 0-45 ° to increase the outward radial force. In some embodiments, the fixed portion 1710 can be parallel to the outwardly facing surface of the valve support 120.

When the orientation of the anchoring portion 1710 is at least substantially parallel to the longitudinal axis LL or tapering inwardly in the upstream direction, some embodiments of the anchoring member 110 may be a natural valve of a natural heart valve. It is configured to bias the engagement surface 1712 against the tissue at the implantation site at or below the annulus. The fixation portion 1710 may have such a configuration in an unbiased state prior to implantation, or it may have this inwardly tapered configuration through deformation imposed by engagement with tissue at the implantation site. May be. For example, upon engagement with tissue, the anchoring portion 1710 is embedded from an unbiased state where it is oriented at least substantially parallel to the longitudinal axis LL or tapering in an upstream direction toward it. To move into orientation, the fixed portion 1710 can be deflectable over various angles with respect to the longitudinal axis LL. As described in more detail below, the large, generally cylindrical region of the outer surface of the anchoring portion 1710, and the orientation of the anchoring portion 1710 in the direction P-P, is dependent on the annulus of a natural mitral valve or other heart valve and Provides good fixation to the sub-annular tissue. In some embodiments, the fixed portion 1710 may have a height of 10mm~20mm the _{(H f).}

  The fixing portion 1710 of the fixing member 110 may have regions having different inflexibility in the radial direction along the PP axis. These regions can conform to the surrounding anatomy or provide an outward radial force on it to provide fixation and sealing. In one embodiment, the radial inflexibility may be greater in the region of the fixed portion downstream of the annulus and less in the region in contact with and downstream of the annulus. This combination resists compression and ensures that the device maintains its fixation to the anatomy when subjected to a systolic pressure gradient, while allowing some compression (annulus). A region in the annulus that maintains a radially outward force sufficient to hold a fixed portion in contact with the anatomy to provide a seal between the device and the anatomy Would provide.

  Radial inflexibility may be controlled by the design of the structural elements of the attachment portion 1720 and / or the side 1730, the taper angle or curvature between these regions and the fixed portion 1710, or a combination of these characteristics. . The design of the structural element 1711 of the fixed portion 1710 may have different characteristics (wall thickness, width, length, angle, etc.) along with the PP axis to provide different radial inflexibility regions. Good. In addition, the anchoring portion 1710 can have a first flexibility and integrated region 1720 and / or the side 1730 has a second flexibility that is different from the first flexibility. be able to. The anchoring portion 1710 may itself have a first flexible downstream region and a second flexible upstream region different from the first flexibility.

  The fixation portion 1710 can further comprise a plurality of tissue engaging elements 170 configured to penetrate into the annulus and / or subannular tissue. The prosthetic heart valve device is preferably secured only by engagement of the anchoring portion 1710 with the natural tissue and resists large blood forces on the device during ventricular systole. Other means of fixation, such as tissue engaging arms or tethers that are connected to natural tissue are not required. Thus, the tissue engaging element 170 ensures that the device moves without penetrating or perforating the leaflets or heart wall tissue completely or otherwise causing inadequate trauma as the heart beats. Configured to engage natural tissue to resist. Because the upstream force during ventricular systole is so great, the tissue engaging element 170 preferably protrudes at least in the upstream direction to prevent movement of the anchoring member 110 in the upstream direction relative to the natural tissue. I will. In some cases, a downstream protruding tissue engaging element may also be desirable (eg, protruding above in the case of a mitral valve) because a smaller force is exerted on the device in the downstream direction during diastole. In one embodiment, the securing portion 1710 protrudes upward and downward with a top row 171a of tissue engaging elements projecting upward and downward, and a second row 171b of tissue engaging elements also projecting upward and downward. A third row of tissue engaging elements 171c. The tissue engaging element 170 may be a heel, tines, pin, or other element that penetrates or otherwise grasps the natural annulus tissue and / or the sub-annular tissue. In some embodiments, the tissue engaging element 170 protrudes radially outward from the structural element 1711 of the fixation portion 1710 at a distance of approximately 0.5-5 mm.

  The integrated region 1720 of the anchoring member 110 can be formed from the lower portion of the structural element 1711. In the embodiment illustrated in FIGS. 73 and 74, the integration region 1720 includes a plurality of rhombus structures 1722 and vertical members 1724. In the illustrated embodiment, each of the vertical members 1724 can include two portions of the structural elements 1711. In some embodiments, the anchoring member 110 and the valve support 120 are made from separate struts, and the integrated region 1720 is the attachment or fastening portion of the anchoring member 110 attached to the valve support 120. For example, when the anchoring member 110 and the valve support 120 are separate components, the integration region 1720 can be a mounting portion that includes a plurality of connection points 1726, where the integration region 1720 is a valve support. 120. In one embodiment, the integrated region 1720 of the anchoring member 110 can be connected to the valve support 120 at multiple (eg, twelve) connection points 1726 using nitinol rivets. In other embodiments, fibers, adhesives, solder, laser welding, metal bolts, or other mechanical features, or other types of fasteners are used to secure the support 120 to the integrated region 1720. it can. Thus, the integrated region 1720 can be a fastening portion.

  In other embodiments, the anchoring member 110 and the valve support 120 are integrally formed together from a common strut, or several struts are integral with both the anchoring member 110 and the valve support 120. Can be formed. In these embodiments, the integrated region 1720 is a structure that transitions from the securing member 110 to the valve support 120 without being otherwise fastened together. For example, the integrated region 1720 is curved or otherwise bent of such a strut between the cylindrical valve support 120 and the portion of the anchoring member 110 that projects away from the valve support 120. Can be part.

  In the embodiment shown in FIGS. 72-74, the side 1730 extends between the upper region of the integrated region 1720 and the lower region of the fixed portion 1710. The side portion 1730 extends laterally outward from the integrated region 1720 to the fixed portion 1710, for example. In one embodiment, the side 1720 includes a plurality of connectors 1732 having a transverse section 1733 (FIG. 74) formed from a portion of the structural element 1711. The lateral section 1733 of the connector 1732 extends laterally, which in some embodiments is straight outward, conical, curved, or outwardly inclined (eg, flared) in a longitudinal axis. It is transverse to LL. In addition, the “transverse direction” includes any non-parallel direction with respect to the longitudinal axis LL. The connector 1732 extends from the orientation of the fixed portion 1710 to the transverse section 1733 of the connector 1732 transverse to the longitudinal axis LL, substantially parallel to or inclined inwardly toward the longitudinal axis LL. There may be a curved first transition zone 1734. In many embodiments, the transverse section 1733 of the connector 1732 is substantially perpendicular or perpendicular to the longitudinal axis LL. The connector 1732 can also have a second transition area 1736 that curves from the transverse section 1733 of the connector 1732 to an orientation of an integrated region 1720 that extends at least substantially parallel to the longitudinal axis LL. (FIG. 73). In the embodiment shown in FIG. 73, the first transition zone 1734 has an angle of approximately 60 ° to 160 ° (eg, approximately 90 °) from the transverse section 1733 to the orientation of the engagement surface 1712 of the securing portion 1710. Bending inward and / or upward. The second transition zone 1736 is a downstream and / or downward bend of an angle ranging from 75 ° to 160 ° (eg, approximately 90 °) from the lateral section 1733 of the connector 1732 to the integration region 1720. possible. A smaller angle results in an S-shape, and a larger angle results in a gradual transition as shown in FIG. Thus, the first transition zone 1734 can be curved concave with respect to the longitudinal axis LL, and similarly the second transition zone 1736 can be curved convex with respect to the longitudinal axis LL. Can be. The curvature of the first transition zone 1734 and the second transition zone 1736 suggests that the anchoring portion 1710 is in contact with the annulus and leaflet of the natural heart valve, with the large engagement surface 1712 contacting the good of device 1700. Makes it possible to provide secure fixing. The connector 1732 also ensures that the fixed portion 1710 bends based on the shape of the natural annulus and that all the forces of such deflection of the fixed portion 1710 are the upstream portion of the valve support 120 to which the prosthetic valve 130 is attached. Allows contraction of the left ventricle that is not transmitted to 121. Thus, the device 1700 ensures that the prosthetic leaves of the prosthetic valve 130 maintain sufficient mutual contact after the anchoring member 110 is implanted in the natural mitral valve and to prevent regurgitation during left ventricular contraction. Providing enhanced fixation to natural tissue and sufficient mechanical isolation between the fixation portion 1710 and the upstream portion 121 of the valve support 120.

  In some embodiments, as described above, the integrated region 1720 and side 1730 can individually or collectively define a connection structure that interconnects the anchoring member 110 and the valve support 120. The connection structure comprises a plurality of struts, each having an inner end connected to or integral with the valve support 120 and an outer end connected to or integral with the anchoring member 110. it can. For example, the connection structure can be a skirt that extends outwardly from the valve support 120 upstream, and in selected embodiments, when the anchoring member is at the implantation site, the connection structure is a natural valve. It can be configured to be disposed entirely downstream of the wheel. The connecting structure can have an upstream end connected to the anchoring member such that when the anchoring member is at the implantation site, the upstream end is positioned below the natural annulus.

  Accordingly, the anchoring member 110 can include a fixed portion 1710 and a connection structure 1720/1730, the connection structure 1720/1730 having an inner end connected to the valve support 120 and an outer end connected to the fixed portion 1710. , Extending outward from the valve support 120, and having an intermediate portion between the inner and outer ends. The intermediate portion can, for example, spread outward in the upstream direction.

  The securing portion 1710 can have a skirt that covers the inwardly facing surface of the securing portion 1710, and in additional embodiments, the skirt can further cover the inwardly facing side of the connection structure. In addition, the device 1700 can further include a tubular valve cover extending around the valve support, and the skirt can be attached to the tubular valve cover. In an additional embodiment, the valve cover is disposed on the inwardly facing surface of the valve support.

  75 is a side view of another embodiment of a prosthetic heart valve device 1700, and FIG. 76 is a bottom view of the prosthetic heart valve device 1700 shown in FIG. In this embodiment, the connector 1732 of the side 1730 is defined by a laterally extending portion of the individual structural element 1711 that extends between the fixed portion 1710 and the integration region 1720. Referring to FIG. 76, each connector 1732 includes a single one of the structural elements 1711 as opposed to two structural elements 1711 as shown in FIGS. In addition, the connector 1732 is inclined at a non-perpendicular angle with respect to the longitudinal axis LL of the device 1700. Nevertheless, the connector 1732 includes a first transition 1734 that bends from the connector 1732 to the fixed portion 1710 and a second transition area 1736 that bends from the connector 1732 to the integration region 1720, respectively.

  FIG. 77 is a side view of a prosthetic heart valve device 1700 according to another embodiment of the present technology. In this embodiment, the device 1700 encloses a portion of the first sealing member portion 140a around the periphery 1714 of the securing portion 1710 of the anchoring member 110. The section of the first sealing portion 140a wound on the peripheral edge 1714 provides an atraumatic rim to protect the left atrial lid during implantation and use.

  FIG. 78 is an isometric view of a prosthetic heart valve device 1700 according to yet another embodiment of the present technology. In this embodiment, the material of the second sealing portion 140b on the interior of the valve stent 120 has openings 142a-142c spaced from each other around the valve support 120. The openings 142a to 142c are spaced between commissures where the artificial valve 130 is attached to the second sealed portion 140b. In operation, open regions 142a-142c are expected to reduce static blood volume on the atrial side of device 1700, reduce fibrin and thrombus deposition, and provide better flow dynamics.

  79A and 79B are a partial cross-sectional view and side view of a heart (H) of an embodiment of a prosthetic heart valve device 1700 illustrating an embodiment of a method for implanting a prosthetic heart valve device 1700 according to the present technology. Referring to FIG. 79A, device 1700 is attached to delivery device 1800 (shown schematically) and inserted into the heart (H) via a transapical approach in a low-profile configuration (not shown). Device 1700 is inserted over the natural mitral valve (MV) (arrow S). The fixation portion 1710 of the device 1700 can be positioned in the left atrium (LA) at this stage of the procedure, and then the relative motion between the outer member 1810 and the inner member 1820 of the delivery device 1800 is from the delivery device 1800. The securing portion 1710 can be released. The anchoring portion 1710 can then be expanded using self-expansion or a balloon or other mechanical expander to a partially deployed state where the integrated region 1720 remains attached to the delivery device 1800. In the partially deployed state shown in FIG. 79A, the anchoring portion can have a larger diameter than the opening defined by the annulus (AN) of the mitral valve (MV). In selected embodiments, the outer diameter of the fixed portion 1710 of the device 1700 may be between approximately 38 mm and 56 mm, depending on the size and shape of the mitral valve (MV) natural annulus (AN). It will be appreciated that other sizes may be used depending on the particular anatomy of the patient.

  FIG. 79B illustrates the prosthetic heart valve device 1700 after being positioned at a desired location relative to the annulus (AN) of the natural mitral valve (MV). The device 1700 is moved to the position shown in FIG. 79B by moving the delivery device 1800 (FIG. 79A) down (arrow W) until the fixed portion 1710 contacts and securely engages the annulus (AN). To reach. In some embodiments, the peripheral edge 1714 of the fixed portion 1710 can project slightly above the annulus (AN). Accordingly, the peripheral edge 1714 can be positioned approximately 1-5 mm above the natural annulus (AN), in such embodiments, on the anterior apex (AL) side of the atrium (LA). In other embodiments, the perimeter 1714 of the anchoring portion 1710 may be such that the anchoring portion 1710 is at least on the annulus (AN) and potentially the anterior and / or posterior leaflets (PL) of the mitral valve (ML). ) At the upper peripheral edge of the annulus (AN) or below it. In still other embodiments, the peripheral edge 1714 of the anchoring portion 1710 can be positioned at the sub-annular (SA) location below the annulus (AN) (not shown in FIG. 79B). After device 1700 is positioned at the desired location relative to the annulus (AN) of the mitral valve (MV), delivery device 1800 (FIG. 79A) is pulled down (arrow W in FIG. 79A) and from the patient. Removed.

  In the embodiment shown in FIG. 79B, the device 1700 is implanted such that the peripheral edge 1714 is approximately 1-5 mm above the natural annulus (AN). Since the diameter of the anchoring portion 1710 in the expanded configuration is larger than the diameter of the natural annulus (AN), the outer surface of the anchoring portion 1710 and the tissue engaging member 170 firmly secure the anchoring member 110 against the mitral valve (MV). keep.

  FIG. 79C is embedded at a location slightly lower than the position shown in FIG. 79B so that the peripheral edge 1714 of the fixed portion 1710 urges outward under a portion (AN1) of the natural annulus (AN). FIG. 3 is an anatomical cross-sectional view of the heart (H) showing the device 1700. Device 1700 can also be implanted below the elevation shown in FIG. 79C. For example, the peripheral edge 1714 of the fixed portion 1710 can be positioned at the bottom of the annulus (AN) or at an altitude EE in the space below the annulus (SA). In all of these embodiments, the portion of the natural annulus (AN) on the peripheral edge 1714 further restricts the device 1700 from moving upward into the left atrium (LA) during ventricular systole.

  FIG. 79D is a schematic diagram illustrating an embodiment of embedding the device 1700 as shown above in FIG. 79B or 79C or as shown in many other applications. 79D, an outwardly protruding portion of the anchoring member 110 extending from the valve support 120 to the fixed portion 1710, which can be a laterally curved connection structure 1730a in FIG. 79D, is shown in FIGS. 79B and 79C. Preferably located entirely downstream of the natural annulus (AN). For example, the transition zone 1734 between the connection structure 1730a and the fixed portion 1710 can be used to push or drive the downstream end of the fixed portion 1710 outwardly below the annulus (AN) ( AN) can be placed under the lower part (LMV). This is because the upstream force on the prosthesis 1700 during the ventricular systole results in an upward force on the annulus (AN) and the fixed part 1710 and the annulus (AN) of the fixed part 1710 relative to the annulus (AN). Anchoring member 110 engages tissue on the downstream surface of the natural annulus so that it is resisted by both friction between and the outward stress of engagement of tissue engaging element 170 with natural tissue. Make it possible to do.

The fixing member 110 and the valve support 120 can be configured such that the downstream end of the valve support 120 is disposed 26 mm or less downstream of the natural annulus (AN). In addition, the securing portion 1710 can be configured such that the engagement surface has a width (eg, height) of at least about 10-20 mm. In addition, the connection structure can have a height (H _{i in} FIG. 73) of about 0-15 mm or less downstream from the end of the valve support 120 to the outer end of the fixed portion 1710. The total height of the device 1700 (H _t , FIG. 73) may be approximately 16-26 mm.

  The large contact area of the engagement surface 1712 (FIG. 73) facing the tissue located at or near the annulus (AN) provides a very good fixation to keep the device 1700 in the desired location. The tissue engaging element 170 around the fixation portion 1710 further enhances fixation of the device 1700 to the annulus (AN) region. The transverse orientation of the connector 1732 further provides significant outward support of the fixed portion 1710 such that it exerts a sufficient outward force on the annulus (AN), and the orientation and configuration of the connector 1732 further includes the valve support ( 79) (not shown in FIG. 79B) at the end of the integrated region 1720 and isolate the upstream portion of the valve support from the force exerted by the securing portion 1710 to prevent the mitral valve (MV) from being implanted. Fits regular shapes and movements. Also, as noted above, the anchoring member may further include a natural valve, along with friction and radial hoop forces exerted by the securing portion 1710 and tissue engaging elements as described above with reference to FIGS. 79B-79D. The device 1700 is secured to the anatomy by compressing upward against the bottom or lower portion of the annulus (AN). Testing of device 1700 further indicates that tissue has grown in and around anchoring portion 1710 and further anchors device 1700 in the desired location relative to the annulus (AN).

  80A-80P are schematic cross-sectional views of several additional embodiments of a prosthetic heart valve device 1700 according to the present technology, and FIG. 80Q is an isometric view thereof. As a reference, the numbers refer to similar or identical components of FIGS. 72-80Q. The embodiment of device 1700 illustrated in FIG. 80A represents some of the embodiments described above with reference to FIGS. 72-79D. In this embodiment, the connector 1732 extends at an angle α of 30 ° to 90 ° with respect to the longitudinal dimension LL of the device 1700. As the angle α approaches 90 degrees, the load on the valve support 120 from the fixed portion 1710 increases for angles less than 90 degrees. Thus, a greater taper (eg, a smaller angle α) reduces the load transmitted to the valve support 120 and the prosthetic valve 130.

  FIG. 80B illustrates an embodiment of a device 1700 where the connector 1732 has an S-shape. One advantage of having an S-shaped connector 1732 is that the valve support 120 can be shortened to reduce the extent to which the device 1700 protrudes into the left ventricle and impedes flow through the LVOT. As noted above, the lower end of device 1700 can interfere with flow through the LVOT during ventricular contraction.

  FIG. 80C shows a device 1700 in which the anchoring member 110 is inverted such that the fixed portion 1710 is disposed around the downstream portion 123 of the valve support 120 and the integrated region 1720 is attached to the upstream portion 121 of the valve support 120. FIG. This embodiment of the device 1700 positions the valve support 120 further in the left atrium rather than the left ventricle.

  FIG. 80D illustrates an embodiment of a device 1700 in which the fixed portion 1710 is oriented downward and positioned at a height downstream of the valve support 1720. This embodiment is expected to prevent transmission of load from the fixed portion 1710 to the valve support 120, which also reduces the valve support 120 to reduce the valve support 120 from protruding into the left ventricle. Position.

  FIG. 80E illustrates an embodiment of the device 1700 where the valve support 120 is offset relative to different regions of the fixed portion 1710. In this device, the anchoring member 110 includes a first connector 1732a between the fixed portion 1710 and the valve support 120 on one side of the device 1700 and a valve support 120 and the fixed portion 1710 on the other side of the device 1700. And a second connector 1732b. The first connector 1732a can be shorter than the second connector 1732b so that the valve support 120 is closer to the fixed portion 1710 on one side of the device compared to the other side of the device. The embodiment of the device 1700 illustrated in FIG. 80E may advantageously position the valve support 120 and the prosthetic valve 130 further away from the LVOT so as to reduce interference with blood flow during ventricular contractions. In addition, the embodiment of the device 1700 shown in FIG. 80E is expected to provide a more uniform load distribution to match the non-circular shape of the mitral annulus and the profile of the heel.

  FIG. 80F illustrates an embodiment of the device 1700 in which the integration region 1720 of the anchoring member 110 is attached to the middle portion of the valve support 120 rather than the end of the valve support 120. The embodiment of the device 1700 illustrated in FIG. 80F may reduce the interaction between the fixed portion 1710 and the valve function.

  FIG. 80G illustrates another embodiment of a device 1700 in which the valve support 120 has a commissure mounting structure 128 having an extension 1728 that protrudes radially inward from the downstream end of the commissural mounting structure. The extension 1728 can be focused inward at a desired angle toward the central axis of the device 1700. In one embodiment, the angle of the extension 1728 maintains an appropriate minimum required bend radius so that the extension 1728 can be linearized to minimize the diameter of the valve during deployment. The integrated region 1720 of the securing member 110 can be attached to the extension 1728. The embodiment of device 1700 illustrated in FIG. 80G is expected to increase the minimum required bend radius for connector 1732 and reduce the height of fixed portion 1710 for a given taper angle. Inward extensions 1728 may also provide an attachment point that is advantageous for commissure of valve tissue. By moving this attachment point further into the ventricle and toward the centerline of the valve, the overall stress on the valve tissue will be reduced. If the leaflet free edges are slightly shorter than the commissures, the free edges will not touch these extensions 1728 in the open position. Therefore, blood flow will not be disturbed and the leaflets will not be damaged by repeatedly touching the dilation.

  FIG. 80H is a cross-sectional view of another embodiment of a prosthetic heart valve 1700 according to the present technology. In this embodiment, the side 1730 has a shape that flares outwardly from the downstream end 123 of the valve support 120, and the integrated region 1720 has the anchoring member 110 attached to the valve support 120. At the end of side 1730. The first transition zone 1732 of the side 1730 bends up from the side 1730 to the orientation of the fixation portion 1710 such that the fixation portion 1710 is configured to face the tissue of the natural mitral valve. Thus, this embodiment shows a side 1730 that is wide and extends laterally.

  FIG. 80I is a cross-sectional view of another embodiment of a prosthetic heart valve 1700 according to the present technology. In this embodiment, the side 1730 has a conical shape that projects outwardly from the downstream end 123 of the valve support 120, and the integrated region 1720 is the side 1730 where the anchoring member 110 is attached to the valve support 120. At the end of. The first transition zone 1732 of the side 1730 bends up from the side 1730 to the orientation of the fixation portion 1710 such that the fixation portion 1710 is configured to face the tissue of the natural mitral valve. Thus, this embodiment shows a conical laterally extending side 1730.

  FIG. 80J is a cross-sectional view of another embodiment of a prosthetic heart valve 1700 according to the present technology. In this embodiment, the side 1730 has an arm that is slightly convex when viewed from the downstream end or concave when viewed from the upstream end. In this embodiment, systolic blood pressure on the valve and valve support imparts a compression column load on each of the arms. Due to the slightly bent shape of the arm, this gives the arm a slight bending load in the downstream direction. At the same time, the systolic blood pressure on the arm itself and the attached sealing part imparts a slight bending load on the arm upstream. By optimizing the curvature of the arm, the net bending load on the arm due to blood pressure can be minimized or eliminated.

  FIG. 80K is a cross-sectional view of another embodiment of a prosthetic heart valve 1700 according to the present technology. In this embodiment, the side portion 1730 has a shape that flares outwardly continuously from a location at or near the upstream end 121 of the valve support 120, and the integrated region 1720 includes the securing member 110. At the apex of the side 1730 attached to the valve support 120. The first transition zone 1732 of the side 1730 bends from the side 1730 to the orientation of the fixation portion 1710 such that the fixation portion 1710 is configured to face the tissue of the natural mitral valve. Thus, this embodiment shows an inverted, skirted and laterally extending side 1730. Side 1730 may be integrally formed with a fixed portion 1710 or may be a separate structure that is attached to fixed portion 1710 by welding or other suitable means. In the latter case, the transition zone 1732 may either bend upward so that the tip of the side 1730 points in the upstream direction or bend downward so that the tip of the side 1730 points in the downstream direction.

  80L and 80M are cross-sectional views of additional embodiments of a prosthetic heart valve 1700 according to the present technology. In these embodiments, the side 1730 extends radially from the central section 118 of the valve support 120 (FIG. 80L) or from the upstream end 121 of the valve support 120 (FIG. 80M). In other embodiments, the side 1730 may extend radially from a tip at or near the downstream end of the valve support 120. Referring to FIGS. 80L and 80M, side 1730 is radially compressible to allow serpentine or zigzag cross-section and / or radial movement of fixed portion 1710 toward and away from valve support 120 or Other configurations can be provided that are deflectable and elastic to bias the fixed portion 1710 radially away from the valve support 120.

  FIG. 80N shows a prosthetic heart in which the anchoring member 110 is inverted such that the fixed portion 1710 is disposed around the downstream portion 123 of the valve support 120 and the integrated region 1720 is attached to the upstream portion 121 of the valve support 120. 12 is a cross-sectional view of another embodiment of valve 1700. FIG. In this embodiment, the side 1730 has a shape that flares continuously outward from a point at or near the upstream end 121 of the valve support 120. This embodiment of the device 1700 positions the valve support 120 further in the left atrium rather than the left ventricle.

  FIG. 80O is a cross-sectional view of another embodiment of a heart valve 1700 in which the securing portion 1710 of the anchoring member 110 is disposed around the central section 118 of the valve support 120. In this embodiment, the anchoring member 110 includes a first side 1730a having a shape that flares outwardly from a point at or near the upstream end 121 of the valve support 120, and the valve support 120. Is attached to the valve support by a second side 1730b having a shape that flares outwardly from a point at or near its downstream end 123.

  FIG. 80P is a cross-sectional view of another embodiment of a heart valve 1700 that is sized so that the securing portion 1710 of the anchoring member 110 is substantially coextensive with the valve support 120 in the axial or longitudinal direction. It is. In this embodiment, the anchoring member 110 extends from a first side 1730a that extends from an integrated region 1720 located in the central section 118 of the valve support 118 and from an integrated region 1720 in the central section 118. Attached to the valve support 120 by the second side 1730b. The first and second sides, 1730a, 1730b may be integrally formed with each other and / or with the fixed portion 1710.

  FIG. 80Q is an isometric view of another embodiment of a prosthetic heart valve device 1700 according to the present technology. In this embodiment, the securing portion 1710 includes an extension 1713 that extends downstream from the first transition zone 1734. The extension 1713 can be formed by an extension of the selected structural element 1711 that projects downstream beyond the region where the transition zone 1734 enters the fixed portion 1710. The extension 1713 increases the height of the fixed portion 1710 and further enhances sealing and ingrowth in the downstream portion of the fixed portion 1710. For example, the expansion 1713 can enhance ingrowth in the ventricular portion of the fixed portion 1710 of the mitral valve device.

  FIG. 81A is a cross-sectional view schematically illustrating a prosthetic heart valve device 1900, according to another embodiment of the present technology. Device 1900 can include a securing member 110, a valve support 120, and a prosthetic valve 130. Device 1900 can further include a compartment 1910 attached to one or both of anchoring member 110 and valve support 120. The compartment 1910 can be configured to fit between the anchoring member 110 and the valve support 120. The compartment 1920 can extend around only a portion of the circumference of the anchoring member 110, or the compartment 1910 can extend around the entire inner circumference of the anchoring member 110. The compartment 1910 can further include a second portion 1910a that protrudes toward the left atrium and provides more space to fit into a thin configuration.

  In one embodiment, compartment 1910 is made from a fiber, mesh, braid, porous material, or other suitable material that can contain material 1920. A fiber, mesh, or other material can be optimized on one end to minimize blood flow therethrough during the first period after implantation, while the other end is It may be more open to allow even more aggressive tissue ingrowth and compartment 1910 angiogenesis. Material 1920 can be, for example, a sustained release agent that prevents or prevents clotting (eg, clopidogrel or aspirin), a healing agent (ascorbic acid), or other agents that promote tissue and growth. Material 1920 may alternatively include structural filling elements such as globules, irregular interdigitated fibers, foams, swellable hydrogels, either in place of or in addition to anticoagulants and healing agents, Can be included. These globules, fibers, foams, etc. can be optimized with respect to their compressibility. In this way, the structural filling element can provide structural support between the anchoring member 110 and the valve support 120 without completely transmitting the force from the anchoring member 110 to the valve support 120. it can. The compartment 1910 can be attached to the anchoring member 110 or the valve support 120 by a fastener 1930 such as, for example, a clasp, a fiber bond, or other suitable fastener. Material 1920 may be introduced into the device after the device has been deployed into the patient, for example via a tube extending from compartment 1910 to the proximal end of the delivery system. Once compartment 1910 is filled with material 1920, the tube can be withdrawn from compartment 1910 with a self-sealing valve that prevents leakage of material 1920 from the compartment.

  FIG. 81B is a top view of a prosthetic heart valve device 1900 illustrating an embodiment in which the compartment 1910 has a plurality of separate cells 1912 (identified individually as cells 1912a-1912g). Each of the cells 1912 can include the same material 1920 (FIG. 81A), or several cells can include different materials 1920. For example, cells 1912a, 1912c, 1912e, and 1912g can include an anticoagulant and cells 1912b, 1912d, and 1912f can include a healing agent that promotes the healing of connective tissue.

  FIG. 82A is an isometric view of a prosthetic heart valve device 2000 according to another embodiment of the present technology, and FIG. 82B is a cross-sectional view of the device 2000 along line 20B-20B of FIG. 20A. Device 2000 can include a fixation member 110 having a frame and a plurality of tissue engaging elements 170 similar to the fixation portion 1710 of device 1700 described above. The device 2000 can further include one or more fibers or webs 2010 that flexibly couple the anchoring member 110 to the valve support 120. The web 2010 can be a fiber, mesh, braid, sheet, or other material formed from, for example, a fabric, polymer, metal, natural fiber, or other suitable material. These webs may have various orientations.

  Referring to FIG. 82B, the web 2010 includes a first portion 2012 at the upstream end of the valve support 120, a second portion 2014 at the downstream end of the valve support 120, and a fastening member 110 and a valve support by a fastener 2020. And a side portion 2016 attached to the body 120. The web 2010 illustrated in FIG. 82B can form an encapsulated compartment 2018 that can be filled with a sustained release agent and / or a material such as a filling element as described above. Fastener 2020 may be a suture, other filament bond, clasp, rivet, or other suitable fastening means. Additional fibers or webs may extend from the downstream end of the anchoring member to the upstream end of the valve support, from the upstream end of the anchoring member to the downstream end of the valve support, or in other directions. Alternatively, a vertically radially oriented planar web may extend from the anchor member to the valve support.

  The device 2000 illustrated in FIGS. 82A and 82B has no metal indirect points and the suture fastener 2020 adds additional stability and potentially good fatigue life, so that the anchoring member 110 and the valve support 120. Can provide very good force isolation between. The device 2000 is made of a durable material that can be used for the web 2010 (eg, Kevlar®, a trademark of EI du Pont de Nemours and Company) and the flexibility of the web 2010 for fatigue life. Has the potential to further improve

  FIG. 83 is a schematic cross-sectional view of a device 2000 according to another embodiment of the present technology. In this embodiment, the web 2010 has an upper portion between the anchor member 110 and the upstream end of the valve support 120, and the sides are connected to the anchor member 110 and the valve support 120 by fasteners 2020. In this embodiment, the device 2000 further includes a tether 2040 attached to the downstream end of the anchoring member 110 and an intermediate region of the valve support 120.

  84A-84C are schematic cross-sectional views illustrating aspects of some embodiments of prosthetic heart valve devices 1700, 1900, and 2000 in accordance with the present technology. Referring to FIG. 84A, the device 1700 has a fixed portion 1710 that extends inwardly from the side 1730 (eg, a connection structure) toward the device longitudinal axis at an angle of 45 ° outwardly away from the device 1700 longitudinal axis. It can have a fully expanded state that extends to an angle of −30 ° in the orientation. Fixed portion 1710 extends substantially parallel to the longitudinal axis of the device in the embodiment shown in FIG. 84A. The device 1700 may have such a fully expanded state outside the body or after the device 1700 is implanted in a natural valve. However, the fixed portion 1710 is at least partially adapted to the shape of the natural valve location so that it is also at least partially compatible with the angled orientation of the tissue of the natural valve location, inwardly or It can be bent or otherwise deformed when implanted, so as to deflect outward (arrow D). For example, FIG. 84B shows the inward deflection of the fixation portion 1710 to match the tissue angle below the natural annulus (AN), and FIG. 84C shows the other side of the natural annulus (AN). The outward deflection of the anchoring portion 1710 is shown to match the tissue angle. Such dual compatibility enhances fixation of the device to natural tissue. In addition, the fixed portion 1710 need not be deflected relative to the side 1730 in the central section of the fixed portion 1710, as shown by the solid line in FIG. 84A, but rather the fixed portion 1710 is illustrated by the dashed line in FIG. 84A. Can be deflected around the area at or near the end of the fixed part, as indicated by the lateral section transition areas 1730 'and 1730' '.

  85A-85C are side views illustrating selected embodiments of deflection of the fixed portion 1710 relative to the side 1730. FIG. Referring to FIG. 85A, the fixed portion 1710 can be connected to the outer end of the side 1730 by a hinge 1737. In the embodiment shown in FIG. 85B, the fixed portion 1710 is deflected around a first transition zone 1734 where the side 1730 bends relative to the fixed portion 1710. FIG. 85C shows an embodiment in which the securing portion 1710 is attached to the side 1730 by a mechanical fastener 1738 such as a pin, bolt, rivet, or other fastener. In any of these embodiments, the fixation member may pivot, rotate, flex, or otherwise deflect inwardly oriented 1710 ′ or outwardly oriented 1710 ″ depending on the tissue at the implantation site. can do.

  86A-107B illustrate a prosthetic heart valve device 2100 having an expansion member 2110, according to additional embodiments of the present technology. Similar to the devices discussed above with respect to FIGS. 10A-85C, device 2100 includes features such as valve support 120 (eg, FIG. 86B) having an interior 134 to which prosthetic valve 130 (eg, FIG. 86B) is coupled; An expandable anchoring member 110 (eg, a anchoring member having a tubular anchoring frame) coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the anchoring member 110 when implanted. ). 86A is a side view of device 2100 including features generally similar to those of prosthetic heart valve device 1700 described above with reference to FIGS. 72-85C and FIG. 86B is an isometric view thereof. Similar to device 1700, the anchoring member such that anchoring portion 1710 of anchoring member 110 is configured to engage natural tissue above or downstream of the annulus to prevent movement of device 2100 in the upstream direction. 110 can be coupled to the valve support 120.

  In the embodiment illustrated in FIGS. 86A and 86B, the device 2100 also includes an expansion member 2110 that extends from the anchor member 110 (eg, from a securing portion 1710 of the anchor member 110). The expansion member 2110 may be an expansion ring that protrudes from or is anchored to an edge, flange, shoulder, or fixed portion 1710 of the anchoring member. In one embodiment, the expansion member 2110 is positioned upstream of the natural annulus and is configured to engage tissue upstream of the natural annulus, while the anchoring member 110 is at the annulus or leaflet. Or configured to engage tissue in the vicinity thereof. In some arrangements, the expansion member 2110 includes: (a) the device 2100 within the native valve region so that the device 2100 is correctly installed within the native valve to ensure proper engagement and retention by surrounding tissue. Alignment and positioning and / or (b) deflection, deformation in response to engagement with natural tissue in a manner that can be visualized using fluoroscopy, echocardiography, or other visualization methods Assisting in visualization and detection of the position of the device relative to the anatomy, and / or (c) during operational use as a prosthetic valve in the patient's heart during implantation by moving otherwise A self-expanding retainer configured to engage tissue in an upstream heart chamber (eg, the left atrium) to prevent movement in the downstream direction.

Referring to FIG. 86A, the expansion member 2110 has a cross-sectional dimension that is greater than the cross-sectional dimension D1 of the outer periphery 150 of the upstream portion 112 (eg, fixed portion 1710) of the anchoring member 110 when the device 2100 is in the expanded configuration 2102. It may have an outer periphery 2112 with D _4. In other embodiments, the expandable member 2110 is at least a natural valve or long axis 55 as large as the ring, or even greater than that, may have a cross-section transverse dimension D _4. In some embodiments, the outer perimeter 2112 of the expansion member 2110 may be on the annulus such that the expansion member 2110 is deflected upstream by the atrial wall when the expansion member 2110 is deployed above the annulus. having a cross-section transverse dimension D ₄ is greater than the surface. In some embodiments, when fully expanded and undeformed, the cross-sectional dimension D ₄ of the expansion member 2110 is approximately 1.2 to 3 times the cross-sectional dimension D ₁ of the securing portion 1710 of the anchoring member 110. It can be. In a specific embodiment, the fully expanded, unbiased, undeformed expansion member 2110 has a transverse dimension D ₄ in the range of about 40 mm to about 150 mm, or about 40 mm to about 80 mm for adult patients. May be. In some embodiments, the expansion member 2110 can be non-circular (eg, oval or D-shaped) in the transverse / horizontal plane, and in such embodiments, about 40 to about 150 mm, preferably about 40. It may have an outer diameter in the range of ~ 80 mm, the outer diameter being about 1.2 to 2 times its inner diameter. Also, in accordance with aspects of the present technology, the expansion member 2110 may be provided in a plurality of transverse dimensions and / or shapes to fit various natural valve sizes, with an appropriate size and shape for each patient. Allows the surgeon to choose.

In some embodiments, the expansion member 2110 can be configured to align the device 2100 relative to the natural annulus by engaging tissue upstream of the natural annulus. When the device is delivered to the target site via a delivery catheter (not shown), the expansion member 2110 has an anchor 110 member and a valve support in or on the annulus, as described in further detail below. It expands within the atrial cavity before being released from the delivery catheter nearby. In these embodiments, the expansion member 2110 rests on or above the annulus surface before the rest of the device 2100 (eg, the anchoring member 110 and the valve support 120) is released from the delivery device. Pulled down against the surface. When the expansion member 2110 is engaged with the upper surface of the annulus, the securing portion 1710 is properly aligned longitudinally with respect to the natural valve, so that the securing portion 1710 is the desired annulus and / or leaflet tissue. The total height of device 2100 (H _t , FIG. 86A) and / or the fixed height of fixed portion 1710 (H _f , FIG. 86A) can be configured to engage. In other embodiments, the expansion member 2110 is configured to deflect or deform when it engages the atrial wall or supra-annular surface while the remainder of the device 2100 is advanced in the downstream direction. . The degree of deflection or deformation correlates with the longitudinal position of the fixed portion 1710 relative to the natural annulus, thereby enabling visualization of the expansion member 2110 using fluoroscopy, echocardiography, or other means. The position of device 2100 can be accurately determined prior to full deployment.

  In some embodiments, the expansion member 2110 is coupled either directly or indirectly to the upstream portion 112 of the anchoring member 110 (eg, the upper perimeter or the upstream perimeter 113) when the device 2100 is in the expanded configuration 2102 It may be an extension of the material that projects in a non-coaxial (or transverse) direction relative to the anchoring member 110. In the deployment configuration 2104 in a natural mitral valve (see, eg, FIG. 89B), the expansion member 2110 extends upstream through the annulus AN and into the supra-annular space in the atrium, and the supra-annular surface or Other atrial tissue can be engaged with the outwardly extending flange or edge 2120.

  The expansion member 2110 comprises a coating or sheet of material such as flexible fibers, rings, disks, or webs (eg, fiber fabrics, braids or lattices, shape memory polymer materials, and / or shape memory metals). An edge 2120 may be included. In one embodiment, as shown in FIGS. 86A and 86B, the edge 2120 can include a sheet of flexible material that is coupled to the anchoring member 110 near the upstream end or portion 112, from the anchoring member 110. Extends radially outward. In one embodiment, the device 2100 is coupled to a first sealing member portion 140a (FIG. 86B) coupled to a wall (eg, inner wall) of the anchoring member 110 and to a wall (eg, inner wall, outer wall) of the valve support 120. And a second sealing member portion 140b to be connected. As discussed above with respect to the device 1700 illustrated in FIG. 72, the first and second sealing member portions 140a and 140b can be an integral part of a single sealing member, or the fastening member 120 and It can be a separate sealing member that is independently attached to the valve support 120. Similarly, in one embodiment, the edge 2120 can have an inner end 2122 that is coupled to the first sealing member portion 140a. For example, the edge 2120 and the first sealing member portion 140a can be a continuous sheet of material. In another embodiment, the edge 2120 and the first sealing member portion 140a include attachment means such as stitching, sutures, rivets, adhesives, or other mechanical coupling fasteners or features known in the art. Can be used together. In such embodiments, the edge 2120 and the first sealing member portion 140a may be formed of the same material or different materials. In certain embodiments, the first sealing member portion 140a and the edge 2120 may prevent perivascular leakage between the device 2100 and adjacent tissue and / or promote tissue ingrowth of adjacent tissue. Therefore, it can be formed of an impermeable material (eg, tissue such as Dacron® or pericardium). In another example, edge 2120 may be formed of a different material (eg, shape memory metal) or a combination of metals, fibers, tissues, and / or other materials having the desired flexure or shape memory characteristics. Can do.

  The expansion member 2110 is further similar to that optionally included on the sealing member 140, as described above in connection with FIGS. 43A-43B, integrated with the expansion member 2110, or coupled thereto or otherwise. May include a tissue engaging element 170a, such as a scissors, step, tines, bar, or similar structure attached to. These tissue engaging elements 170a may be configured to engage atrial wall or supra-annular tissue to prevent movement of device 2100 in the downstream direction (towards the ventricle). The tissue engaging element 170a may be non-penetrating or slightly penetrate the surface of the tissue to prevent migration. In an exemplary embodiment, the tissue engaging element can be oriented to have a higher retention force against movement in the downstream direction than in the upstream direction, preferentially pointing in the downstream direction. Alternatively, or in addition, the tissue facing surface outside the expansion member 2110 may enhance frictional forces and / or natural at least until tissue ingrowth occurs sufficiently to prevent device movement. It may be coated with a permanent or temporary adhesive or other material to adhere to the tissue.

  In some embodiments, the expansion member 2110 can also include a support structure 2130 that is coupled to the edge 2120 or, in other embodiments, integral with the edge 2120 (FIG. 86B). Support structure 2130 may provide additional rigidity to expansion member 2110 as expansion member 2110 extends radially outward from anchoring member 110 when device 2100 is in an expanded configuration 2102. In some arrangements, the support structure 2130 can be an inflexible member formed from a metal and / or polymer material that is sewn, sewn, or bonded to the edge 2120. In some embodiments, the support structure 2130 can include an elastic metal or polymer mesh, ring, or series of rings that are coupled to, or otherwise integrated with, a portion of the edge 2120. In certain embodiments, the support structure 2130 can be formed from a deformable material or from an elastic or shape memory material (eg, nitinol). In other embodiments, the support structure 2130 can include one or more inflexible members, such as wires 2132 or struts, secured to the outer surface or positioned within the material of the edge 2120.

  In one embodiment, the support structure 2130 can be separate from the frame 2109 and / or the anchoring member 110. For example, FIG. 86B includes a wire 2132 (eg, a plurality of struts) in which the support structure 2130 is formed in a cross-shaped configuration and forms a continuous ring around the expansion member 2110, as well as the wire 2132 directly with the frame 2109. Figure 3 illustrates an embodiment without contact. In this embodiment, the expansion member 2110 is connected to the anchoring member 110 (eg, at the fixation portion 1710) by the material of the edge 2120 (eg, fiber or tissue). In some embodiments, expansion member 2110 (including edge 2120 and optional support structure 2130) is connected to anchor member 110 only by fibers, sutures, or other highly flexible non-metallic elements. Is done. Thus, in this embodiment, the wire 2132 is structurally independent of the anchoring member 110 such that the support structure 2130 is indirectly coupled to the frame 2109 by an edge 2120 (eg, fiber, material, etc.). Thus, under undeformed or unbiased conditions, the support structure 2130 is spaced from the frame 2109 of the anchoring member 110 and mechanically isolated from the frame 2109. While the embodiment illustrated in FIG. 86B illustrates a generally coaxial array of wires forming a cross-shaped serpentine pattern (eg, zigzag pattern, rhombus pattern), other arrangements and patterns (eg, serpentine, Waves, radial arms, squares, etc.) can also be formed to provide the desired rigidity to the expansion member 2110, as described below with respect to FIGS. 87A-107B.

  In further embodiments, as illustrated in FIGS. 87A and 87B, the support structure 2130 can be integral with a frame 2109 (eg, a Nitinol frame) of the anchoring member 110. 87A and 87B are a side view and a top view, respectively, of a device 2100 having an expansion member 2110 that includes a support structure 2130 formed from an extension of the frame 2109. FIG. For example, the support structure 2130 includes an integral wire 2134 (eg, a strut) (FIG. 87A, dotted line) that extends from the structural element 2111 of the frame 2109 into the edge 2120. As illustrated in FIG. 87B, the monolithic wire 2134 provides a pattern (eg, straight and outwardly projecting struts 2134a and to provide a desired combination of stiffness and flexibility around the edge 2120. (Combination of support columns 2134b oriented in a triangle). In some embodiments, the monolithic wires 2134 that connect the support structure 2130 to the frame 2109 are more individually or aggregated than structural elements of the frame 2109, depending on their number, size, geometry, or other manner. Substantially flexible so that the expansion member 2109 is deflected or deformed relatively easily when it engages natural tissue. For example, the number of integral wires 2134 that interconnect the expansion member 2110 to the frame 2109 around the circumference of the device 2100 may be significantly less than the number of structural elements 2111 around the circumference.

  In another embodiment, the support structure 2130 is at one or more connection points using rivets (eg, Nitinol rivets), filaments, adhesives, solder, laser welding, metal bolts, or other mechanical features. Other types of fasteners can be connected to the frame 2109 or can be used to secure the support structure 2130 to the frame 2109 of the anchoring member 110. In some arrangements, the support structure 2130 can be coupled to the frame 2109 with a plurality of flexible connecting members (not shown) that are substantially less rigid than the frame 2109. In this embodiment, the flexibility of the expansion member 2110 can allow the expansion member 2110 to be distorted without distorting the anchoring member 110 and / or the valve support 110. Various aspects of this arrangement can allow the expansion member 2110 to be shape-matchable, and in some embodiments, more atraumatic to the supra-annular tissue and the atrial wall. Can be made possible. In some embodiments, the wires 2132 or struts may have a stiffness or inflexibility that is less than the inflexibility stiffness of the structural element 2111 of the frame 2109. In these embodiments, the expansion member 2110 can be deformed by the peripheral supra-annular tissue and / or atrial wall without transmitting force to the stiffer frame structure of the anchoring member 110.

  88A-88C are cross-sectional views of the heart illustrating a method for delivering a prosthetic heart valve device 2100 to a native mitral valve MV in the heart using a transapical approach, according to another embodiment of the present technology. Referring to FIG. 88A, the delivery catheter 18 is advanced through a guiding catheter (not shown) that enters the left ventricle LV of the heart through a puncture in the left ventricular wall at or near the apex and by purse string suture Sealed. Alternatively, delivery catheter 18 may be placed directly through a transapical incision sealed with a purse string suture without a guiding catheter. The sheath 20 containing the folded device 2100 of the radially contracted delivery configuration 2106 is advanced through the mitral annulus AN between the native leaflets LF, as shown in FIG. 88A. The valve support 120, anchoring member 110, and expansion member 2110 (eg, edge, flange, shoulder, enlargement ring, etc.) are positioned at or near the natural mitral valve when in the delivery configuration 2106. It has a low profile that is configured for delivery through the catheter 18. Referring to FIGS. 88B-88C together, once the device is positioned such that the expansion member 2110 is located in the atrium, the sheath 20 is configured so that the device 2100 is in a radially expanded and / or deployed configuration 2102, 2104 (FIGS. 88B and 88C). ) Is pulled proximally to allow expansion to.

  As with the other devices disclosed herein, retraction of the sheath 20 may cause the delivery system to remain connected to the device 2100 (eg, a system eyelet not shown is a device eyelet not shown). Allows the device 2100 to expand. In this manner, the operator controls the placement of device 2100 while at least a portion of device 2100 (eg, expansion member 2110, upstream portion 112 of anchoring member 110) is in expanded configuration 2102 (FIGS. 88B and 88C). can do. For example, when the sheath 20 is disengaged from the device 2100, the upstream region 112 of the anchoring member 110 is retained within the sheath 20 while the dilating member 2110 can expand within the left atrium (FIG. 88B). During this stage of delivery, the position of device 2100 within the mitral valve region can be adjusted or changed.

  In one embodiment, the expansion member 2110 can have an indicator portion 2116 (FIGS. 88C and 89B) that can be visualized during device implantation to determine the position of the device 2100 relative to the native annulus. In one embodiment, the deflection of the indicator portion 2116 caused by engagement of the expansion member 2110 with the left atrial wall (eg, when treating a mitral valve) accurately determines the position of the device 2100 relative to the native annulus. Can be visualized. In some arrangements, indicator portion 2116 is preferably deflected about an axis that is generally parallel to the plane containing the natural annulus. In another arrangement, the indicator portion 2116 forms an angle with the surface containing the natural annulus, the angle increasing as the indicator portion 2116 is deflected. In certain positioning and deployment steps, the expansion member 2100 can be positioned such that the indicator portion 2116 forms a first angle with the surface during the visualization step, and then the indicator portion 2116 is deployed with the anchor member 110. The device 2100 is moved to form a second angle with the surface that is less than the first angle before Since the position of the fixed portion 1710 (FIG. 86A) relative to the expansion member 2110 is known for a given degree of deflection, the position of the fixed portion 1710 relative to the natural annulus is dependent on the degree of deflection of the expansion member 2110 (ie, the second The angle can be determined based on the angle. For example, the indicator portion 2116 can include a radiopaque material coupled to or integrated with the edge 2120 and / or the support structure 2130, wherein the radiopaque material is fluoroscopic. Can be visualized using.

In another example, indicator portion 2116 can include an echogenic material that is visualized using ultrasound. In further embodiments, the indicator portion may include one or more metallic members. In some embodiments, the device 2100 can also include a gas (eg, CO ₂ ) pocket, or chamber, in or associated with the expansion member 2110 that enhances echocardiographic visibility. For example, the expansion member 2110 can be made of closed cell foam or other material with a gas pocket. In another embodiment, the expansion member 2110 (eg, support structure 2130) can include a platinum core to enhance fluoroscopic visibility. The platinum core wire may be removable so that once the device 2100 is properly positioned and embedded, the platinum core wire can be removed to avoid galvanic reaction with the NiTi wire.

  After the device 2100 is located at the target site, the sheath 20 can be completely removed from the device 2100 so that the anchoring member 110 of the device 2100 engages with sub-annular tissue, such as the leaflet LF, and as desired. Can be expanded outward to hold the device 2100 at its target location. Following the positioning and deployment of device 2100 where expansion member 2110 is positioned, conforms to tissue above the annulus, and anchoring member 110 engages the annulus and / or sub-annular tissue, the puller wire (Not shown) may be retracted proximally to release device 2100 from the delivery system. The delivery system can then be removed so that the device 2100 is fully implanted in the mitral valve MV in the deployed configuration 2104. Alternatively, device 2100 is expanded upstream or downstream of the desired target location and then retracted or pushed into the target location downstream or upstream, respectively, before releasing device 2100 from the delivery system. Also good.

  89A and 89B are schematic top views of a natural mitral valve in the heart as seen from the left atrium, showing the prosthetic treatment device of FIGS. 86A and 86B implanted in the natural mitral valve, according to an embodiment of the present technology. . During deployment, the device 2100 can be moved from a radially contracted delivery configuration (FIG. 88A) from an expanded member 2110 from an anchoring member 110 (eg, upstream perimeter 113 and / or fixed portion 1710) to an annulus surface of a natural valve. And / or configured to transition to an unbiased / expanding configuration 2102 (FIG. 89A) that expands radially outward over the atrial wall surrounding the natural valve. Prior to fully releasing device 2100 from the delivery catheter, the catheter may be moved in a downstream direction (towards the ventricle) to position the fixation portion in the desired location relative to the native annulus (FIGS. 88B-B). 88C). In doing so, the outer portion of the expansion member 2110 may be deflected upward and radially inward by contact with atrial tissue (FIGS. 88C and 89B). This deflection can be visualized using fluoroscopy and / or echocardiography, thereby indicating to the practitioner the vertical position of the device 2100. As illustrated in FIG. 89B, the device 2100 includes at least a portion of the expansion member 2110 that engages and at least partially thereby engages the supra-annular surface or tissue above the natural valve (eg, the atrial wall). A final deployed configuration 2104 can be formed that is deformed.

  In many embodiments, the expansion member 2110 may be sufficiently flexible so that the expansion member 2110 conforms to the annulus and atrial wall anatomy when in the deployed configuration 2104 (FIG. 89B). it can. Thus, during implantation in a natural valve (eg, a natural mitral valve), the expansion member 2110 is directed toward the expanded configuration 2102 and its bias toward the deployed configuration 2104 (FIG. 89B) that extends further in the upstream direction. Can be deformed or deflected by natural tissue. While the expansion member 2110 is deflectable in the upstream direction (FIG. 89B), the expansion member 2110 extends in the radial direction and biases downward against the upper surface of the annulus (FIGS. 86A-86). 87B and 89A) are elastically biased back. This biasing holds the expansion member 2110 in the atrium (eg resists movement toward the left ventricle under axial compression force during diastole and / or atrial contraction) and positioning of the device 2100 relative to the natural annulus. Contribute to the maintenance of Further, the resulting compression fit between the expansion member 2110 and the supra-annular surface and / or atrial wall or other structure facilitates tissue ingrowth and encapsulation (eg, into the edge 2120). This helps create a long-term bond between the tissue and the device 2100.

  The flexible nature of the structural element 2111 of the frame 2109 (FIG. 86A), having the first sealing member portion 140a and the support structure 2130 and edge 2120, is an uneven and uniquely shaped natural tissue in the natural mitral valve. The flexibility and conformability of the anchoring member 110 and the expansion member 2110 can be enabled to engage and seal the device 2100 with respect to each other. Although the expansion member 2110 and the anchoring member 110 are deformable in response to forces exerted by the natural anatomy, the valve support 120 can be substantially isolated from such deformation and / or circular. Alternatively, it has sufficient rigidity to maintain the other original cross-sectional shape, thus ensuring proper bonding of the leaflets of the prosthetic valve 130 when implanted. The mechanical isolation of the prosthetic valve 130 from the forces exerted by the natural tissue is independent of the deformability of the portion of the anchoring member 110 that is spaced from the valve support 102, as well as the independent deformability of the expansion member 2110 and the atria. It may be achieved by positioning.

  As explained above, the mechanical isolation of the valve support 120 from the anchoring member 110 may be due to some aspects of the prosthetic heart valve device disclosed herein. Some of these aspects include, but are not limited to: (a) the flexibility of the anchoring member 110, or the anchoring member 110, which is relatively high compared to the lower flexibility of the valve support 120. The flexibility of the transverse element connecting the fixed part 1710 of the valve to the valve support 120, and (b) between the anchoring member 110 and the valve support 120, particularly in some embodiments, the anchoring member 110 is a natural valve. A radial spacing at the upstream portion / upstream end that engages the annulus and / or subannular tissue, and (c) a coupling mechanism (eg, connection structure 1720) employed to attach the anchoring member 110 to the valve support 120. / 1730, FIG. 73) can be configured to reduce the transmission of force from the anchoring member 110 to the valve support 120 (eg, to be flexible, compressible, or movable). May include .

  In device 2100, anchoring member 110 can also be mechanically isolated from expansion member 2110. When deployed in a natural mitral valve, the expansion member 2110 is more substantially affected by the atrial anatomical force and by the atrial diastolic force, while the anchoring member 110 is in the annulus or It is more substantially affected by anatomical forces in its vicinity (eg, the lower side) and / or by ventricular systolic forces. The device 2100 is configured to conform to the shape and movement of the anatomy under these forces by mechanically isolating the anchoring member 110 from the expansion member 2110 and from the valve support 120. In one embodiment, the expansion member 2110 can be significantly deformed when deployed and in operation without substantially affecting the deformation of the anchor member 110 during operation. Compared with the flexibility of the valve support 120, it can have a relatively high flexibility. In another embodiment, the expansion member 2110 can have a deformable portion 2114 (FIG. 89A) that is mechanically isolated from the anchoring member 110 such that the deformable portion 2114 substantially displaces the anchoring member 110. Can be deformed in the radial direction and / or the longitudinal direction without being deformed. The expansion member 2110 also allows the form and location (e.g., upper perimeter or upstream perimeter 113) to allow for deformability of the expansion member 2110 without substantially affecting the shape of the anchoring member 110 or the valve support 120. Thus, it can be connected to the fixing member 110. Also, the coupling mechanism employed to attach the expansion member 2110 to the anchoring member 110 may reduce the transmission of force from the expansion member 2110 to the anchoring member 110, or vice versa (eg, flexible Or can be configured to be movable).

FIGS. 90A-90F are schematic diagrams illustrating how a prosthetic heart valve device mechanically isolates the valve support 120 from forces exerted by natural tissue, according to additional embodiments of the present technology. Reference to forces exerted by natural tissue can include, in some embodiments, diastolic and systolic forces generated in the beating heart, or in other embodiments, natural that can vary from patient to patient. Forces exerted by anatomical differences in the valve can be included. In one embodiment shown in FIG. 90A, the lateral force F _H1 exerted on the device 2100 is such that the anchoring member 110 and / or the expansion member 2110 prevents the valve support 120 from being deformed by the force F _H1 . Is absorbed by. In this embodiment, the device 2100 can have a central longitudinal axis L-L, and the lateral force F _H1 can be at a different laterally offset position relative to the axis L-L at the anchoring member 110 and the expansion member 2110. Can be deformed or otherwise moved, while the valve support 120 does not move substantially relative to the axis LL. The expansion member 2110 also allows the anchoring member 110 to move a first distance DIS ₁ in the transverse direction relative to the longitudinal axis LL, so that the expansion member 2110 is greater than, equal to, or different from the distance DIS _{1 in the} transverse direction. as can it move less than the second distance DIS ₂ form, it is also mechanically isolated from the fixing member 110. In some cases, all three elements (stick member 110, expansion member 2110, and valve support 120) can be in three different offset positions in the transverse direction with respect to axis LL.

In another embodiment, multiple moment forces F _A1 and F _A2 exerted on the device 2100 from natural tissue can also be absorbed by the anchoring member 110 and / or the expansion member 2110 (FIG. 90B). For example, the moment forces F _A1 , F _A2 exerted by the natural tissue are center longitudinal of the anchoring member 110, the expansion member 2110, and the valve support 120 such that each element is at a different angle with respect to the longitudinal axis LL. The positioning (eg, XY positioning, rotational positioning, etc.) can be independently changed with respect to the axis. As illustrated in FIG. 90B, the expansion member 2110 can be deformed, tilted, or moved at an angle independent of the deformation or angle of the anchoring member 110, and vice versa.

In a further embodiment, anchoring member 110 and expansion member 2110 are relative to expanded configuration 2102 (eg, FIGS. 86A and 86B) when forces transmitted from surrounding tissue are absorbed by anchoring member 110 and expansion member 2110. , Can undergo a relative shape change. In the example illustrated in FIGS. 90C-90E, the transverse compressive force is such that the device 2100 is positioned and held at the native valve site and that the valve support 120 remains substantially undeformed under the same conditions. As such, it can be absorbed by portions of the anchoring member 110 and / or the expansion member 2110. In one embodiment, the absorption of the transverse compressive forces F _H2 and F _H3 by the anchoring member 110 may be without deformation or less deformation of the expansion member 2110 under the same and / or different applied forces. , Can cause the upstream portion 112 of the anchoring member 110 to deform inwardly (FIG. 90C). Alternatively, the downstream end of the expansion member 2110 may be deformed in the transverse direction without deformation of the upstream end of the anchoring member 110 or with less deformation.

In other embodiments, as illustrated in FIGS. 90D and 90E, the force causes the shape of the expansion member 2110 to be different from the shape of the anchoring member 110 resulting from the same or different forces in the horizontal plane. Can change. For example, the expansion member 2110 may have a horizontal force F _H4 and F _H5 (eg, in the atrium) that is different from the forces F _H2 and F _H3 (eg, at or downstream of the annulus) exerted on the anchoring member 110. (FIG. 90D). As a result, the expansion member 2110 can be ovalized with its long axis in the first direction, while the anchoring member 110 is oval with its long axis in the second direction transverse to the first direction. Turn into. FIG. 90E shows that lateral forces F _H2 , F _H3 , F _H4 , and F _H5 are absorbed by the expansion member 2110 and the fixation member 110, thereby deforming the expansion member 2110 into a D shape, while the fixation member 110. FIG. 4 illustrates another embodiment in which has a different shape in a horizontal plane, such as circular, oval, or non-aligned D-shape.

Figure 90F is a fixing member 110 and the extension member 2110, when the force in the vertical direction transmitted from the surrounding tissue _{F L1} and _{F L2} is absorbed by the fixing member 110 and the extension member 2110, in the enlarged configuration 2102, the relative shape Fig. 4 illustrates an embodiment through a change of In this embodiment, the longitudinal mechanical forces F _L1 and F _L2 can cause distortion of the expansion member 2110 and the anchoring member 110 so that these elements have different shapes along the transverse axis TT of the device 2100. Side profile with For example, the expansion member 2110 may have a saddle shape that corresponds to the shape of the upper annulus surface of the natural valve, while the anchoring member 110 remains substantially cylindrical or is, for example, arcuate It is deformed to a different shape with the side profile of

  FIG. 91A is an isometric view of another device 2100 having an expansion member 2110 in accordance with the present technology. The expansion member 2110 shown in FIG. 91A includes an edge 2120 formed of fibers or another suitable material, and the edge material 2124 is at least partially configured to provide a support structure 2130 for the expansion member 2110. And has structural features such as wrinkles 2125 in the fiber. The scissors 2125 can be sewn, stitched, secured with adhesive, or formed using other mechanical features such as a binding. The ridges 2125 in the edge material 2124 can be patterned or positioned for the desired strength, stiffness, and / or flexibility. For example, the ridge 2125 can have a coaxial, radial, zigzag, serpentine, diamond, square, or other pattern in the edge 2120. Optionally, one or more structural elements (eg, metal wires, plastic elements, etc.) are sewn or attached to the edge 2120 to provide additional structure and / or scissor (s) 2125.

  91B is a cross-sectional view of ridge 2125 in expansion member 2110 shown in FIG. 91A. The folds 2125 are sewn or fixed portions of the edge material 2124 arranged in a different pattern in a circumferentially spaced manner, radially or around the edge 2120 obtain. Some ridges 2125a may not have additional incorporated elements, while other ridges 2125b may have structural elements such as wires 2132 positioned within the ridge 2125b (FIG. 91B). In some embodiments, the structural element or other element can be radiopaque to assist in visualization of the device during and after implantation in the native valve. The device 2100 illustrated in FIGS. 91A and 91B provides a conformable, easily compressible and atraumatic expansion member 2110 that does not apply or transmit deformation force to the anchoring member 110 or valve support 120. To do.

  FIGS. 92-95B are schematic top views of several additional embodiments of a prosthetic heart valve device 2100 in accordance with the present technology. As a reference, the numbers refer to similar or identical components of FIGS. 86A-95B. The embodiment of the device 2100 illustrated in FIG. 92 represents some of the embodiments described above with reference to FIGS. 86A-91B. In this embodiment, the expansion member 2110 includes a support structure 2130 that includes wires 2132 that form a series of loops 2135 positioned circumferentially around the edge 2120. The loop 2135 may provide increased resiliency in the edge 2120 while still providing sufficient flexibility for the expansion member 2110 to deflect upstream. The loop 2135 may also provide a support structure 2130 that atraumatically engages tissue.

  FIG. 93 illustrates an embodiment of the device 2100 in which the support structure 2130 includes a plurality of corrugated coaxial wires 2132 positioned circumferentially around the edge 2120. FIG. 94 illustrates an embodiment of the device 2100 where the support structure 2130 includes spiral / spiral shaped wires 2132, 2136 positioned circumferentially around the edge 2120. The illustrated embodiment of FIG. 94 includes a single wire 2132 formed in a coaxial spiral / spiral pattern, while other wires (not shown) are in a spiral / spiral pattern, or another It can be included to form a pattern (eg, double helix, double spiral, etc.). The support structure 2130 illustrated in FIGS. 93 and 94 provides sufficient flexibility to align and deflect relative to the anchoring member 110 about an axis transverse to the direction of blood flow through the prosthetic valve 130. Axial strength can be provided while still maintaining.

  95A and 95B are coupled to the frame 2109 of the anchoring member 110, or otherwise integral therewith, and project in a plurality of spirals extending radially toward the outer periphery 2112 of the expansion member 2110. Additional embodiments of the device 2100 are illustrated where the support structure 2130 includes radiation 2136. Radiation 2136 may have an atraumatic tip 2137 and / or a tissue engaging portion so that the supra-annular tissue and / or atrial wall is not damaged during deployment or engagement by expansion member 2110. In some embodiments, the atraumatic tip 2137 can be an upper loop portion 2137a at the end of the radiant 2136 (FIG. 95A). In other embodiments, the atraumatic tip 2137 can be a bent portion 2137b.

  96A-96C illustrate another embodiment of a device 2100 having a support structure 2130 with atraumatic features. As shown in FIGS. 96A and 96B, the device 2100 includes a rounded or curved expansion member 2110 having a plurality of elastic coils 2138 coupled to an edge 2120. In one embodiment, the expansion member 2110 shown in FIG. 96A is configured to conform to the natural anatomy without inducing trauma. The expansion member 2110 can also enhance self-alignment of the device 2100 (eg, reduce tilting relative to the annulus). For example, the expansion member 2110 can counteract forces that would cause the device 2100 to tilt during systole. Further, one or more components of the expansion member 2110 can be used to visualize the shape of the expansion member 2110 and thereby detect or position the device 2100 during deployment.

  The coil 2138 can extend from the frame 2109 of the anchoring member 110 toward the outer periphery 2112 of the expansion member 2110 (FIG. 96B), or in another embodiment, the coil 2138 can be spaced from the frame 2109. In one embodiment, the coil 2138 is deflectable at least in an upward direction, but is biased toward a radially outward orientation at a rounded, downwardly oriented end 2139. In one embodiment, the coil 2138 can be damaged from nitinol (NiTi), polyetheretherketone (PEEK) polymer, stainless steel, or other suitable material. In various embodiments, the coil 2138 includes a shape memory metal. In further embodiments, the expansion member 2110 can include an edge 2120 formed from a fiber, woven material, knitted material, mesh or web made from polyester, or other flexible material (FIG. 96C). . In still further embodiments, the edge 2120 may be NiTi, stainless steel, (PEEK) polymer, the edge 2120 alone or another material used to form the edge 2120 (eg, integrated into a fabric). Can be formed from webs, meshes, knitted materials, or other woven materials made from other suitable materials that can be used to form with. As shown in FIGS. 96A-96C, the expansion member 2110 can be shaped to provide a seal between the native tissue and the device 2100 when the valve is closed and under pressure during ventricular systole. it can. The expansion members of FIGS. 96A-96C can also promote tissue biointegration into the edge 2120 material, which in turn can facilitate long term sealing of the device 2100 to native tissue.

  97A and 97B illustrate a further embodiment of the device 2100 in which the expansion member 2110 includes a discontinuous edge 2120 around the upstream periphery 113 of the anchoring member 110 in accordance with the present technology. 97A and 97B are top and isometric views of a device 2100 having a plurality of discrete, extending petals 2140 or expansion members 2110 that include protrusions extending from the frame 2109 of the anchoring member 110. . The petal 2140 can include wires 2132 or struts extending radially from the frame 2109 to form a plurality of spaced triangular petals 2140 around the upstream perimeter 113 of the anchoring member 110. The wire 2132 can be covered with fibers or other edge material 2124 in a continuous or discontinuous (FIGS. 97A and 97B) manner to define the edge 2120. The petals 2140 are mechanically isolated from each other's petals 2140, and each petal 2140 is deflected and / or deformed independently of each other's petals 2140 to provide enhanced conformity to natural tissue. Configured as follows.

  98A-98C illustrate an additional embodiment of the device 2100 in which the expansion member 2110 includes a plurality of petals 2140 that extend radially from the frame 2109 of the anchoring member 110. For example, FIG. 98A illustrates a device 2100 having a plurality of circular wires 2141 that form individual petals 2140. The circular wire 2141 can be flexibly connected to the frame 2109 around the upstream periphery 113 of the fixing member 110 via a plurality of connectors 2142. In addition, the circular wire 2141 can be covered or otherwise attached to the edge material 2124 to form the edge 2120 (see FIGS. 98B and 98C). In one embodiment, the expansion member 2110 includes fibers or other materials that cover and / or under the circular wire 2141 and extend beyond the circular wire 2141 to form a continuous edge 2120 (FIG. 98B). FIG. 98C illustrates another embodiment in which a circular wire is bonded to discrete portions of the edge material 2124 to form a circular petal 2140 spaced around the upstream perimeter 113 of the anchoring member 110. In this example, each petal 2140 can be mechanically isolated from each adjacent petal 2140 such that the petal 2140 provides the expanded member 2110 with increased consistency to the surrounding natural tissue. Can be deflected and / or deformed independently of the mutual petals 2140. In a further embodiment, to provide some intimate movement within the edge 2120 while still allowing greater freedom for the consistency of the unique tissue anatomy engaged by the expansion member 2110, Petals 2140 can be connected or hinged to adjacent petals 2140 with articulated 2143 or other fasteners.

  FIG. 99 illustrates an additional embodiment of the device 2100 having an expansion member 2110 formed of a polymer sheet 2188 or other panel. In various arrangements, the polymer sheet 2118 allows the expansion member 2110 not to require a support wire and / or allows the use of fewer or smaller wires to form a support structure (not shown). Sufficient strength or / or rigidity can be provided as is possible. In order to provide flexibility to the expansion member 2110, certain embodiments of the polymer sheet 2118 include a plurality of holes 2119 through the polymer sheet material. The holes 2119 can be selected with respect to density, size, and / or location on the polymer sheet 2118 and can be varied to increase and / or decrease the flexibility of selected areas of the expansion member 2110. it can. For example, FIG. 99 illustrates an embodiment of a device 2100 in which holes 2119 are disposed in the polymer sheet 2118 at a greater density toward the outer periphery 2112 when compared to the density in the inner portion 2113 of the polymer sheet 2118. . In this embodiment, the flexibility of the expansion member 2110 is greater toward the outer periphery 2112 than the inner portion 2113, and the region at or near the outer periphery 2112 is more easily deformed to match the natural tissue. Enable. In some embodiments not shown, the density and / or size of the holes 2119 can be unevenly distributed across the polymer sheet 2118 to form a non-uniform expansion member 2110. For example, greater flexibility (eg, greater density of holes 2118) on the side engaging the front leaflet than on the side engaging the back leaflet so that the device 2100 does not substantially occlude the LVOT. It is desirable to provide.

  100A and 100B illustrate another embodiment of a device 2100 having an expansion member 2110 with variable flexibility during and after implantation, according to the present technology. FIG. 100A illustrates the enlarged devices 2100, 2102 after release from the delivery catheter 18, and FIG. 100B is a schematic top view of the device 2100. Referring to FIGS. 100A and 100B together, the support structure 2130 can include a combination of wires having variable inflexibility (eg, flexibility). For example, the support structure 2130 can include a flexible wire 2144 (eg, thin, soft) and can include a relatively inflexible wire 2145 that is less flexible than the flexible wire 2144. . The more inflexible wire 2145 may also have a higher radiopacity than the flexible wire 2144 to facilitate enhanced visualization during device placement. In some embodiments, the more inflexible wire 2145 may be attached within or attached to the edge 2120 so that the more inflexible wire 2145 may be removable during or after implantation of the device 2100. Can be positioned within a pocket or sleeve 2146. The sleeve 2146 may be oriented such that the more inflexible wire 2145 provides radial support to the expansion member 2110 during deployment and implantation (FIG. 100B), although other orientations and arrangements are also possible. . As shown in FIG. 100A, the more inflexible wire 2145 can remain connected to the delivery catheter 18. After placing the expansion member 2110 upstream of the native valve, the more inflexible wire 2145 can be removed from the sleeve 2146 and retracted through the delivery catheter 18. In some embodiments, all the more inflexible wires 2145 can be removed, but in other arrangements, a portion of the more inflexible wires 2145, or selected more inflexible wires, after implantation It can remain in the expansion member 2110. The flexible wire 2144 may remain coupled to the edge 2120 to provide an atraumatic support structure 2130 having increased flexibility once implanted.

FIG. 101 shows a device 2100 in which the support structure 2130 includes one or more inflatable chambers 2147 in the edge 2120 that can be inflated with fluid to provide radial inflexibility to the expansion member 2110. FIG. The edge material 2124 can be, for example, a fiber, polymer, or other material that provides an inflatable chamber 2147 (eg, an internal channel). One or more independent or interconnected inflatable chambers 2147 may be arranged in a continuous ring around expansion member 2110 or in other arrangements (eg, radially extending arms, zigzags, etc.). . In one embodiment, the chamber 2147 is fluid (eg, saline, CO ₂₎ via a port 2148 provided on the edge 2120 either before, during, or after deployment of the device 2100. , Air, gel, contrast agent, etc.). In one embodiment, the chamber 2147 can be at least partially filled during deployment, and the inner fluid after deployment of the expansion member 2110 and / or device 2100 to provide a desired degree of flexibility. The amount of can be adjusted. In various embodiments, the chamber 2147 can be temporarily inflated or deflated prior to the release of the device 2100 from the delivery catheter (not shown). In one embodiment, the expansion member 2110 has radial inflexibility only when expanded. The expansion member 2110 can be structurally independent of the anchor member 110 that is attached, for example, via an edge material 2124 or via a flexible connector (not shown). In some embodiments, when chamber 2147 is filled with a gas (eg, CO ₂ ) or other material that is more visible by echocardiography, expansion chamber 2147 has improved visibility by contrast echocardiography. May provide sex.

  FIG. 102 illustrates an embodiment of a device 2100 where the expansion member 2110 can include an edge material 2124 and / or multiple layers 2150 of a support structure 2130. For clarity purposes, layers 2150 are shown separated in FIG. 102, but layers 2150 are preferably stacked in contact with each other without intervening spaces. In certain embodiments, a plurality of layers 2150 of polymer fiber fabric fibers with one or more layers of wire 2132 provide expansion member 2110 with a selectable degree of conformity or conformity to natural tissue. be able to. Individual layers 2150 of edge material 2124 can be formed of the same material or combination of materials. Similarly, support structure 2130 can include a layer of wire 2132 having the same or different arrangement on layer 2150 of edge material 2124. The wire 2132 can also include a combination of a flexible wire (eg, smaller, less inflexible) and a more inflexible wire. Accordingly, the plurality of layers 2150 may include wires 2132 having different wire diameters, geometries, overall sizes, and inflexibility. In another embodiment, the layer 2150 can provide the expansion member 2110 with an asymmetric degree of flexibility. In one example, the lower layer 2151 (eg, closer to the ventricle) can be inflexible (eg, less flexible) than the upper layer 2152 contacting the atrial cavity tissue. In another example, the expansion member 2110 may include a side that engages the anterior leaflet (eg, greater flexibility) and a side that engages the posterior leaflet or commissure so that the device 2100 does not substantially occlude the LVOT. (E.g., lower flexibility) may have an asymmetric degree of flexibility. In a further embodiment, the expansion member 2110 can also include a radiopaque marker 160 (eg, metal) disposed on or between the layers 2150 to assist in visualization of the device 2100 during and after implantation. Sex strips, rings).

  FIG. 103 illustrates an embodiment of a device 2100 having a funnel-shaped expansion member 2110 extending from the anchoring member 110 in a shape that diverges outward in the upstream direction. In one embodiment, the expansion member 2110 is an inverted funnel-shaped edge that includes an edge material 2124 (eg, fiber) that is coupled to the anchoring member 110 and / or integral with the first sealing member portion 140a. Part 2126 or a tube can be included. In another embodiment, the expansion member 2110 can include an inverted funnel-shaped edge 2126 that is further supported by a support structure comprising struts or wires (not shown).

  104A and 104B show an embodiment of a device 2100 in which the anchoring member 110 includes a plurality of upstream extending ledges 2170 and an expansion member 2110 positioned below (eg, downstream) the ledges 2170. Is illustrated. In one embodiment, the ledge 2170 can be spaced from the radial strut 2171 (FIG. 104A), or in another embodiment, the ledge 2170 can be spaced from the loop 2172 (FIG. 104B). ). The ledge 2170 can be preformed and can be coupled to the frame 2109 of the anchoring member 110 or can be integral therewith. In one embodiment, ledge 2170 may include a metal or other material (not shown) that is visualized by fluoroscopy or echocardiographic imaging systems to visualize the placement of device 2100. it can.

  Referring to FIGS. 104A and 104B together, the ledge 2170 can define the expected final expanded position of the expansion member 2110. Thus, the ledge 2170 may limit deflection of the expansion member as the device 2100 is pulled into position (eg, moved downstream). Alternatively or additionally, the ledge 2170 may provide a fiducial marker that is visualized using fluoroscopy, and the degree of deflection of the expansion member 2110 is assessed relative to the fiducial marker. Also good. As shown in FIGS. 104A and 104B, the angle α is an angle between the expansion member 2110 expanded in the radial direction and the bulge 2170. When the angle α is small, the expansion member 2110 extends more vertically (eg, a thin profile), and the angle α increases as the expansion member 2110 extends outward. Visualizing the angle α during deployment and implantation of the device 2100 may be performed by the practitioner before the valve support (not shown) with the anchoring member 110 and the prosthetic valve is deployed from the delivery catheter (not shown). However, it may be possible to better visualize the position of the device 2100 relative to the native valve anatomy. For example, during surgery, the expansion member 2110 can be at least partially deployed from a delivery catheter (not shown) such that the angle α is large (eg, fully expanded). The device 2100 can then be pulled / pushed downstream through the natural annulus. As device 2100 is retracted / pushed downstream, expansion member 2110 is deflected inward by natural tissue, thereby reducing angle α. Visualization of the decreasing angle α allows the practitioner to confirm the degree of inward deflection associated with the implantation of the device 2100, thus ensuring correct positioning of the device in the native valve.

  FIG. 105 illustrates an embodiment of a device 2100 in which the expansion member 2110 includes an expansion ring 2153 that is separate from the anchoring member 110 in accordance with the present technology. The magnifying ring 2153 is secured to the anchoring member 110 by one or more tethers 2154 or other threads (eg, sutures, fibrous materials, etc.) that span the desired distance between the magnifying ring 2153 and the upstream perimeter 113 of the anchoring member 110. Can be flexibly connected. In one embodiment, the expansion ring 2153 may be formed of a wire frame or a metal mesh. In another embodiment, the expansion ring 2153 may be a cylindrical stent that is connected to the upstream perimeter 113 of the anchoring member 110 and / or the frame 2109 by a tether 2154. In certain embodiments, a cover or other material can be coupled to the expansion ring 2153. In various arrangements, the expansion ring 2153 is structurally independent of the anchoring member 110 (eg, mechanically isolated) and assists in device delivery positioning to ensure proper positioning of the anchoring member 110 prior to deployment. Can also be provided.

  106A and 106B illustrate a device 2100 in which an expansion member 2110 is attached to or otherwise extends from a portion of the valve support 120 (eg, at a location downstream from the upstream portion 112 of the anchoring member 110). FIG. In some embodiments, this may allow higher placement of the device 2100 within a natural annulus (not shown). In the embodiment shown in FIGS. 106A and 106B, the expansion member 2110 is upstream (eg, via stitching, sutures, rivets, adhesives, or other mechanical coupling fasteners or features known in the art). At end 121 (FIG. 106B), or at intermediate portion 2155, can be connected to and / or attached to valve support frame 136 and / or second seal member portion 140b coupled to valve support frame 136. . As illustrated in FIGS. 106A and 106B, and in certain embodiments, the expansion member 2110 can also or alternatively include a cover (eg, an inner skeleton) that covers the gap between the anchoring member 110 and the valve support 120. As provided, the upstream portion 112 may be attached to the anchoring member 110 and / or sealed. The expansion member 2110 may include an edge material 2124 that may be impermeable to blood or alternatively may contain holes that allow it to pass easily through the gap 2108. Alternatively, the expansion member 2110 can have a flap valve (not shown) or other suitable one-way valve (not shown) that allows blood or fluid to flow only into the gap 2108, and the gap At 2108, fluid is captured in the space between the anchoring member 110 and the valve support 120, thus “expanding” the space and adding additional radial stiffness.

  107A and 107B illustrate an embodiment of a device 2100 having a separate expansion member 2180 that is a separately deployable component in accordance with the present technology. Separation expansion member 2180 can have an edge 2120 and a support structure (not shown) similar to expansion member 2110 described above. In other arrangements (not shown), the separating expansion member 2180 can include a support structure (eg, a spiral wire) that is delivered to the top of the annulus (not shown). In addition, the separation extension member 2180 also includes one or more coalescing features 2182 (eg, hooks, etc.) configured to engage the anchoring member 110 (eg, on the frame 2109 at the corresponding hook). Latches, hooks, pins, etc.). In one embodiment, the separation expansion member 2180 can be delivered to the native valve NV by the delivery catheter 18 before delivering the anchoring member 110 that carries the prosthetic valve (107A) to the target site. In some embodiments, the separating expansion member 2180 can engage the upper annulus surface of the annulus A when deployed. Following deployment of the separation expansion member 2180, the anchoring member 110 and the valve support 120 are released from the delivery catheter 18 and engage and are retained by the separation expansion member 2180 in place within the native valve NV. Obtain (FIG. 107B). In one embodiment, the separation expansion member 2180 can remain implanted in the natural valve NV, but in other embodiments, the separation expansion member 2180 can be removed after the prosthetic valve device 2100 is implanted. it can. In other arrangements, the separating expansion member 2180 and the anchoring member 110 can be delivered as a single component, and the valve support 120 carrying the prosthetic valve can be delivered separately.

  Referring again to FIGS. 86A-107B, as well as in the case of mitral valve replacement, the device 2100 has the expansion member 2110 positioned in the left atrium and the anchoring member 110 (eg, the fixed portion 1710) positioned in the natural annulus. As such, it is delivered in a low profile delivery configuration 2106. Device 2100 is partially deployed so that expansion member 2110 is released from delivery catheter 18 and allowed to expand radially while anchoring member 110 is retained in delivery catheter 18. In many of the previous embodiments, the expansion member 2110 easily folds over the anchoring member 110. Thus, the device 2100 is then pulled toward the left ventricle causing the expansion member 2110 to fold inward. The expansion member 2110 exerts a force that properly aligns the anchoring member 110 with the natural annulus, and the relative position between the expansion member 2110 and the anchoring member 110 is easily visualized through known imaging techniques to enable the practitioner. Can allow the device 2100 to be accurately positioned relative to the natural valve structure.

  In addition, as discussed above, the expansion member 2110 is coupled to the fixation member 110 by an edge 2120 or shoulder extending from the fixation member 110, or at least one thread (eg, tether 2154). There can be many different embodiments including a ring 2153. The edges 2120, shoulders, and / or rings are configured to expand to have a larger diameter than the anchor member 110 and to flex, flap, and / or fold over the anchor member 110. Accordingly, the expansion member 2110 is configured to enhance the positioning, orientation / alignment, and visualization of the device 2100 relative to the native valve anatomy. In some but not necessarily all embodiments, the expansion member 2110 can provide additional securing and sealing of the device 2100.

Additional Embodiments The features of the prosthetic heart valve device components described above and illustrated in FIGS. 10A-107B can be modified to form additional embodiments configured in accordance with the present technology. For example, the prosthetic heart valve device 1100 illustrated in FIGS. 65A-65B without a hem anchoring member is coupled to a valve support or other feature and expands radially outward to engage sub-annular tissue. An anchoring member configured as described above can be included. Similarly, the prosthetic heart valve device described above and illustrated in FIGS. 57A-71 can include features such as sealing members and stabilizing features such as arms and tissue engaging elements.

  The features of the prosthetic heart valve device components described above can also be interchanged to form additional embodiments of the present technology. For example, the anchoring member 1210 of the prosthetic heart valve device 1200 illustrated in FIG. 67A can be incorporated into the prosthetic heart valve device 600 shown in FIGS. 57A-57C. In addition, many features of the prosthetic heart valve devices 1700, 1900, 2000, and 2100 described above with reference to FIGS. 72-107B are prosthetic heart valves described above with reference to FIGS. Can be used with the device and vice versa. In certain embodiments, the expansion member 2110 shown in FIGS. 86A-107B can be incorporated into the device 100 (FIG. 10A), for example.

  The following examples illustrate some embodiments of the present technology.

1. A prosthetic heart valve device,
A valve support having an upstream region and a downstream region for blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets. And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
An anchoring member having a longitudinal dimension and including a tissue fixing portion, an integrated region coupled to the valve support, and a plurality of lateral connectors between the tissue fixing portion and the integrated region Wherein the tissue fixation portion is (a) engaged with tissue at a natural annulus of the natural heart valve and / or at an implantation site located downstream thereof; and (b) in the deployed state. Configured to be at least partially deformable into a non-circular shape to conform to the shape of the tissue at the implantation site, wherein the tissue fixation portion faces the tissue at the implantation site in the deployed state. The transverse connector has a transverse section that extends transversely to the longitudinal dimension of the anchoring member and at least a first transition zone that bends in a direction different from the transverse direction. A fixing member; Provided,
When the anchoring member is deformed to the non-circular shape, the tissue fixing portion of the anchoring member is configured so that the upstream region of the valve support maintains the undeformed shape. Said prosthetic heart valve device mechanically isolated from the upstream region.
2. A prosthetic heart valve device,
A tissue fixing portion having a longitudinal dimension and having a first cross-sectional dimension in a deployed state; and an integrated region having a second cross-sectional dimension in the deployed state that is less than the first cross-sectional dimension; A fixation member comprising a side between the tissue fixation portion and the integrated region,
The tissue anchoring portion is (a) engaged with the natural annulus of the heart valve in the human and / or with tissue located downstream thereof; and (b) engaged by the tissue anchoring portion in the deployed state. Configured to be at least partially deformable into a non-circular shape to conform to the shape of the tissue to be
The side portion extends transversely to the longitudinal dimension of the anchoring member such that the tissue fixation portion is configured to face the natural annulus in the deployed state and the transverse An anchoring member having at least a first transition zone that bends from a direction to the tissue fixation portion;
A valve support having a first region and a second region, wherein the first region has a cross-sectional shape configured to support the prosthetic valve in the deployed state, whereby the prosthetic valve A valve support, wherein the prosthetic leaflets contact each other in the deployed state, and the second region of the valve support is coupled to the fixed portion of the anchoring member.
3. 3. The prosthetic heart valve device according to any of examples 1-2, wherein the connector or side further includes a second transition zone that bends from the lateral section or side to the integrated region.
4). The anchoring member has a first end at the tissue fixation portion and a second end at the integration region, and the first transition zone is from the transverse section or side to the anchoring member. Any of Examples 1-3, wherein the second transition zone bends toward the first end of the anchoring member from the lateral section or side. The prosthetic heart valve device according to claim 1.
5. The connector or side further includes a second transition zone, wherein the first transition zone is bent up with respect to the heart and the second transition zone is bent down with respect to the heart; The said artificial heart valve device in any one of Examples 1-4.
6). 6. The prosthetic heart valve device according to any of Examples 1-5, wherein the first transition zone has a concave curvature with respect to the longitudinal dimension of the anchoring member.
7). The connector further comprises a second transition area that bends from the lateral section or side to the integrated region, the second transition area being convex with respect to the longitudinal dimension of the anchoring member. The prosthetic heart valve device of Example 6 having a curvature.
8). 8. The prosthetic heart valve device according to any of examples 1-7, wherein the tissue fixation portion extends at least substantially parallel to the longitudinal dimension of the anchoring member.
9. The longitudinal dimension is a central longitudinal axis of the fixing member, and the tissue fixing portion extends at an angle inclined inward toward the central longitudinal axis. Said prosthetic heart valve device.
10. The artificial heart valve device according to any one of Examples 1 to 9, wherein the tissue fixing portion includes a ring having a regular cylindrical shape and a plurality of ridges protruding from the ring.
11 The prosthetic heart valve device according to any of Examples 1-10, wherein the tissue fixation portion has a height of 10-20 mm and a substantially flat outer surface along the height.
12 The anchoring member has a first end in the tissue fixation portion and a second end in the integrated region, and the second end of the anchoring member is the first end of the valve support. 12. The prosthetic heart valve device according to any of Examples 1-11, connected to a downstream region.
13. The anchoring member has a first end in the tissue fixation portion and a second end in the integrated region, and the second end of the anchoring member is the first end of the valve support. 12. The prosthetic heart valve device according to any of Examples 1-11, connected to an upstream region.
14 14. The prosthetic heart valve device according to any of Examples 1-13, further comprising a compartment between the anchoring member and the valve support and a material in the compartment.
15. Example 15. The compartment according to example 14, wherein the compartment comprises a fiber container attached to the anchoring member and / or the valve support and the material comprises at least one of an anticoagulant and / or a healing agent. Said prosthetic heart valve device.
16. Examples 1-15, wherein the side portion comprises an outwardly flared section, and wherein the fixed portion extends at least substantially parallel to the longitudinal dimension of the anchoring member. Said prosthetic heart valve device.
17. Examples 1-15, wherein the side portion comprises an outwardly extending conical section, and wherein the securing portion extends at least substantially parallel to the longitudinal dimension of the anchoring member. The prosthetic heart valve device according to any one of the above.
18. A device for implantation in a natural mitral valve, said natural mitral valve having a non-circular annulus and leaflet;
A valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets; and a second region;
A first portion having a longitudinal dimension and configured to contact tissue of the non-circular annulus; and a second portion having a side portion between the first portion and the valve support. A fixing member including a portion, and
While the anchoring member and the valve support are in a thin configuration configured to pass through the human vasculature, the second portion of the anchoring member is the second region of the valve support. Attached to the
The side portion traverses the longitudinal dimension;
The securing member and the valve support are from the thin configuration so that the shape of the first region of the valve support is at least partially independent of the shape of the first portion of the securing member. The first portion of the anchoring member is at least partially adapted to the non-circular annulus of the natural mitral valve, and the first region of the valve support is relative to the longitudinal dimension of the anchoring member. The device configured to move to an expanded configuration spaced inwardly from the first portion of the anchoring member.
19. The device of example 18, wherein the first portion of the anchoring member comprises a tissue fixation portion and the second portion of the anchoring member comprises an integral region.
20. The side part comprises a plurality of lateral connectors, and the individual connectors are such that the first part of the anchoring member or the tissue fixing part faces the tissue of the implantation site in the deployed state Any of Examples 18-19, comprising a transverse section extending transversely to the longitudinal dimension of the anchoring member and at least a first transition zone bending in a direction different from the transverse direction. Said device.
21. 21. The device of any of examples 18-20, wherein the connector or side further comprises a second transition zone that bends from the lateral section or side to the valve support.
22. 22. The embodiment of any of Examples 18-21, wherein the first portion or the tissue fixation portion of the anchoring member extends at least substantially parallel to the longitudinal dimension of the anchoring member. device.
23. The longitudinal dimension is a central longitudinal axis of the anchoring member, and the first portion or the tissue anchoring portion of the anchoring member extends at an angle inclined inward toward the central longitudinal axis; The prosthetic heart valve device according to any of Examples 18-21.
24. The artificial heart according to any of Examples 18 to 23, wherein the first part or the tissue fixing part of the fixing member includes a ring having a regular cylindrical shape and a plurality of ridges protruding from the ring. Valve device.
25. The fixing member has a first end in the first part or the tissue fixing part and a second end in the second part or the integrated region, and the first part of the fixing member 25. The prosthetic heart valve device according to any of Examples 18-24, wherein two ends are connected to a downstream region of the valve support.
26. The fixing member has a first end in the first part or the tissue fixing part and a second end in the second part or the integrated region, and the first part of the fixing member 25. The prosthetic heart valve device according to any of Examples 18-24, wherein two ends are connected to an upstream region of the valve support.
27. 27. The prosthetic heart valve device according to any of Examples 18-26, further comprising a compartment between the anchoring member and the valve support and a material in the compartment.
28. The embodiment of any of the embodiments 27, wherein the compartment comprises a fiber container attached to the anchoring member and / or the valve support and the material comprises at least one of an anticoagulant and / or a healing agent. The prosthetic heart valve device according to claim 1.
29. The side comprises an outwardly flared section, and the first or fixed portion of the anchoring member extends at least substantially parallel to the longitudinal dimension of the anchoring member; The prosthetic heart valve device according to any of Examples 18-28.
30. The side includes an outwardly extending conical section, and the first portion or the securing portion of the anchoring member is at least substantially parallel to the longitudinal dimension of the anchoring member. 29. The prosthetic heart valve device according to any of Examples 18-28, which extends.
31. A method for operating a prosthetic heart valve, wherein the prosthetic heart valve device includes an anchoring member and a valve support coupled to the anchoring member in a human heart, the anchoring member comprising a tissue fixation portion. And an integrated region attached to the valve support, and a side between the tissue fixation portion and the integrated region, the method comprising:
Enlarging the anchoring member and the valve support such that the tissue fixation portion has a size and shape spaced from the valve support;
Moving the anchoring member and the valve support such that the tissue fixation portion is deformed into a non-circular shape,
A support region of the valve support is mechanically isolated from the tissue fixation portion of the anchoring member, whereby the support region of the valve support has a predetermined cross-sectional shape for supporting an artificial valve; Wherein the prosthetic leaflets of the prosthetic valve are in sufficient contact with each other to prevent backflow through the prosthetic valve.
32. 32. The method of example 31, wherein the tissue fixation portion of the anchoring member comprises a regular cylinder having an outer surface that extends at least substantially parallel to the longitudinal axis of the anchoring member.
33. The side portion has a transverse section extending transversely to the longitudinal axis of the valve support or the anchoring member, and at least a first bend from the transverse section to the tissue fixation portion. The method of any of Examples 31-32, having one transition zone.
34. 36. The method of embodiment 32, wherein the side further includes a second transition zone having a second bend from the lateral section to the integration region.
35. 35. The method of any of embodiments 33 and 34, wherein the side portion protrudes outward from the integrated region and the first bend is angled upward from the side portion.
36. 35. The method of any of embodiments 33 and 34, wherein the side portion projects outwardly from the integrated region and the first bend is angled downward from the side portion.
37. A method for replacing a natural heart valve having an annulus and a leaflet connected to the annulus, the method comprising:
Positioning a prosthetic heart valve including an anchoring member and a valve support at a location of a natural mitral valve in a patient's heart, the anchoring member having a first portion and a second portion; Positioning the valve support having a first region and a second region;
The first portion of the anchoring member engages tissue above or downstream of the annulus and at least partially conforms to the shape of the annulus at the location of the natural mitral valve; Connecting the second portion of the anchoring member to the second region of the valve support while enlarging the anchoring member and the valve support;
When enlarged, the first region of the valve support is spaced inwardly from the first portion of the anchoring member, and the first region of the valve support has an artificial leaflet And thereby the prosthetic leaflet is sufficient to prevent backflow through the prosthetic valve after the first portion of the anchoring member has conformed to the shape of the annulus of the natural mitral valve Contacting each other.
38. A prosthetic heart valve device,
A valve support having an upstream region and a downstream region for blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets. And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
At an angle that is substantially parallel to the longitudinal axis of the anchoring member or that tapers inward in the upstream direction so that it engages tissue at the implantation site above or below the natural annulus of the natural heart valve. An anchoring member including an outwardly engaging surface configured to extend in an upstream direction, wherein the anchoring portion is deformed into a non-circular shape so as to conform to the shape of the tissue at the implantation site in the deployed state A fixing member that is possible;
A connection structure interconnecting the securing member to the valve support; and
When the anchoring member is deformed into the non-circular shape, the tissue securing portion of the anchoring member is configured to be in the valve support so that the upstream region of the valve support maintains the undeformed shape. The prosthetic heart valve device mechanically isolated from the upstream region.
39. 39. The prosthetic heart valve according to embodiment 38, wherein the connection structure comprises a plurality of struts, each strut comprising an inner end connected to the valve support and an outer end connected to the anchoring member. device.
40. 40. The prosthetic heart valve device according to any of Examples 38-39, wherein the connection structure has a skirt that extends outward in the upstream direction.
41. 41. The prosthetic heart valve according to example 40, wherein the connection structure is configured such that when the anchoring member is at the implantation site, the skirted portion is generally disposed downstream of the natural annulus. .
42. The connection structure has an upstream end connected to the anchoring member, the upstream end configured to be positioned below the natural annulus when the anchoring member is at the implantation site; 42. The prosthetic heart valve device according to any of Examples 38-41.
43 further comprising a plurality of scissors on the fixed surface, the scissors pointing upstream and engaging the tissue to resist upstream movement of the anchoring member relative to the natural annulus The prosthetic heart valve device according to any of Examples 38-42.
44. Embodiments 38- wherein the fixation surface is deflectable over various angles with respect to the longitudinal axis such that upon engagement with the tissue, the fixation surface is movable from an unbiased orientation to an implantation orientation. 44. The prosthetic heart valve device according to any one of 43.
45. 45. The prosthetic heart valve device of example 44, wherein the fixation surface is deflectable over various angles with respect to the connection structure.
46. 46. The embodiment according to any of Examples 38 to 45, wherein the fixed portion has a first flexibility, and the connection structure has a second flexibility different from the first flexibility. Said prosthetic heart valve device.
47. The embodiment has any one of Examples 38 to 45, wherein the fixing portion includes a downstream region having a first flexibility and an upstream region having a second flexibility different from the first flexibility. The prosthetic heart valve device of claim.
48. 48. The prosthetic heart valve device according to any of Examples 38-47, wherein the fixation portion comprises a skirt covering its inward surface.
49. 49. The prosthetic heart valve device of embodiment 48, wherein the skirt further covers an inward side of the connection structure.
50. 49. The embodiment of claim 48, further comprising a tubular valve cover extending around the valve support, wherein the skirt is attached to the valve cover to prevent blood flow between the skirt and the valve cover. Said prosthetic heart valve device.
51. 51. The prosthetic heart valve device of example 50, wherein the valve cover is disposed on an inward surface of the valve support.
52. 52. The prosthetic heart valve device according to any of examples 38-51, wherein the fixed surface is disposed at an angle substantially parallel to the outwardly facing surface of the valve support in an unbiased condition.
53. The valve support has a downstream end, and the securing member is configured such that the downstream end is disposed less than 16 mm downstream of the natural annulus when the engagement surface is at the implantation site. The prosthetic heart valve device according to any of Examples 38-52.
54. 54. The prosthetic heart valve device according to any of examples 38-53, wherein the fixation surface has a width of at least about 10-20 mm in a direction parallel to the longitudinal axis.
55. 55. The prosthetic heart valve device according to 38-54, wherein the connecting structure extends parallel to the longitudinal axis from the inner end to the outer end by a distance of less than about 15 mm.
56. A prosthetic heart valve device,
A valve support having an upstream region and a downstream region for blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets. And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
A fixing member including a connection structure and a fixed portion, wherein the connection structure has an inner end connected to the valve support, an outer end connected to the fixed portion, and between the inner end and the outer end. An intermediate portion extending outwardly in the upstream direction, wherein the anchoring portion generally extends the tissue of the implant site above or below the natural annulus of the natural heart valve downstream of the natural annulus. An outwardly engaging surface configured to engage the skirted portion of the connecting structure disposed, the engaging surface being at an angle substantially parallel to the longitudinal axis of the anchoring member, or upstream An anchoring member extending in an upstream direction at a gradually decreasing angle inward and wherein the anchoring portion is deformable into a non-circular shape to conform to the tissue shape at the implantation site in the deployed state; With
When the fixing member is deformed into the non-circular shape, the fixing portion of the fixing member is configured so that the upstream region of the valve support maintains the undeformed shape. Said prosthetic heart valve device mechanically isolated from the upstream region.
57. A prosthetic heart valve device,
A valve support having an upstream region and a downstream region for blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets. And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
A fixing member including a connection structure and a fixing portion, wherein the connection structure has an inner end connected to the valve support and an outer end connected to the fixing portion, and the fixing portion is the natural member. An outwardly engaging surface configured to engage tissue at an implantation site above or below a heart valve annulus, wherein the anchoring member is a first flexible downstream region And an upstream region having a second flexibility different from the first flexibility, wherein the fixation portion is non-circular so as to conform to the shape of the tissue at the implantation site in the deployed state. A fixing member that is deformable into a shape,
When the fixing member is deformed into the non-circular shape, the fixing portion of the fixing member is configured so that the upstream region of the valve support maintains the undeformed shape. Said prosthetic heart valve device mechanically isolated from the upstream region.
58. 58. The prosthetic heart valve device of embodiment 57, wherein the upstream region is in the anchoring portion and the downstream region is in the connection structure.
59. 58. The prosthetic heart valve device of embodiment 57, wherein the upstream region is in the upstream portion of the fixation portion and the downstream region is in the downstream portion of the fixation portion.
60. A prosthetic heart valve device,
An anchoring member having a tubular securing frame with an inlet end and an outlet end;
A first portion coupled to the anchoring member and a second portion mechanically isolated from the anchoring member, whereby the inlet end of the anchoring member substantially occupies the second portion. A tubular valve support that is radially deformable without mechanical deformation;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support and an open position allowing blood flow downstream through the valve support. A valve having one leaflet;
An expansion member coupled to the stationary frame and extending radially outward therefrom, wherein at least a deformable portion of the expansion member is mechanically isolated from the anchoring member, thereby The prosthetic heart valve device comprising: an expansion member, wherein the deformable portion is radially deformable without substantially deforming the anchoring member.
61. The expansion member includes an edge composed of a sheet of flexible material coupled to the stationary frame and extending radially outward therefrom, and a support structure coupled to the edge; The prosthetic heart valve device of example 60, wherein the support structure is more rigid than the edge.
62. A prosthetic heart valve device,
A fixing member having a connection structure and a radially expandable fixed frame, wherein the connection structure is connected to the fixed frame, and a second end is connected to the valve support. And a fixing member having a side portion separating the fixed frame from the valve support,
Connected to the valve support and movable from a closed position where blood flow through the interior is blocked and an open position where blood flow through the interior is allowed in the direction of flow from the inlet end to the outlet end. A valve having at least one leaflet;
An expansion member,
An edge made of a sheet of flexible material connected to the stationary frame and extending radially outward therefrom; and
An extension member comprising a support structure coupled to the edge, the support structure being more rigid than the edge;
The expansion member is deflectable relative to the fixed frame around an axis transverse to the direction of flow, so that the fixed frame is deformed at least partially independently from the valve support. The prosthetic heart valve device configured.
63. 63. The prosthetic heart valve device according to any of Examples 61 and 62, wherein the support structure is elastic and more flexible than the fixed frame.
64. 64. The artificial heart according to any of examples 60-63, wherein the valve support comprises a generally cylindrical valve frame formed about a longitudinal axis extending between the inlet end and the outlet end. Valve device.
65. 65. The prosthetic heart valve device of embodiment 64, wherein the valve frame has an upper limb and a lower limb, and the anchoring member is coupled to the lower limb of the valve frame.
66. 66. The prosthetic heart valve device of embodiment 65, further comprising a plurality of connecting members that interconnect the lower limbs of the valve frame and the anchoring member.
67. Radially from the upper limb of the valve frame such that the upstream end of the anchoring member is deformable in the radial direction without substantially deforming the upper limb of the valve frame. 68. The prosthetic heart valve device of example 65 that is spaced apart.
68. 64. The prosthetic heart valve device according to any of Examples 61-63, wherein the anchoring member comprises a cover of flexible material connected to and surrounding the fixed frame.
69. 69. The prosthetic heart valve device of embodiment 68, wherein the edge has an inner edge attached to the circumference of the cover.
70. 69. The prosthetic heart valve device of example 68, wherein the edge and the cover comprise a continuous sheet of material.
71. The prosthetic heart valve device according to any of examples 61 and 62, wherein the support structure comprises a plurality of struts.
72. 72. The prosthetic heart valve device of example 71, wherein the struts are not directly connected to the fixed frame.
73. 72. The prosthetic heart valve device of example 71, wherein the struts are spaced from the fixed frame.
74. 72. The prosthetic heart valve device of embodiment 71, wherein the strut is directly coupled to the fixed frame.
75. The expansion member has a biased configuration in which it extends radially outward from the anchoring member and is deflectable to a deflection configuration in which it extends further in the upstream direction, the expansion member being 63. The prosthetic heart valve of any of Examples 60-62, elastically biased back to the configuration.
76. 72. The prosthetic heart valve device of example 71, wherein the struts extend radially away from the fixed frame.
77. 72. The prosthetic heart valve device of example 71, wherein the struts form a continuous ring around an expansion member.
78. 78. The prosthetic heart valve device of example 77, wherein the struts form a wavy, zigzag, or rhombus pattern around the expansion member.
79. 72. The prosthetic heart valve device of example 71, wherein the struts are sewn to the edge.
80. 64. The prosthetic heart valve device according to any of Examples 60-63, wherein the expansion member comprises a plurality of discrete petals extending from an upstream end of the anchoring member.
81. In the deployed state, the fixation frame is configured to engage tissue downstream of the natural annulus of the heart valve and the expansion member is configured to engage tissue upstream of the natural annulus. The prosthetic heart valve device according to any of Examples 60-63.
82. 82. The prosthetic heart of embodiment 81, wherein the expansion member is configured to align the heart valve device relative to the natural annulus by engaging the tissue upstream of the natural annulus. Valve device.
83. 64. The prosthetic heart valve device according to any of Examples 61-63, wherein the support structure comprises an elastic metal or polymer mesh.
84. The artificial structure according to any of embodiments 61 to 63, wherein the support structure is coupled to the fixed frame by a plurality of flexible connection members, and the connection member is substantially less rigid than the fixed frame. Heart valve device.
85. 64. The prosthetic heart valve device according to any of Examples 61-63, wherein the expansion member is connected to the anchor member only by the edge.
86. A prosthetic heart valve device,
An anchoring member having a tubular securing frame with an interior and an upstream end and a downstream end;
Moving from a closed position where the blood flow through the interior is blocked, and an open position where the blood flow through the interior is allowed in the direction of the flow from the upstream end to the downstream end. A valve having at least one leaflet that is possible;
An expansion member,
An edge composed of a sheet of flexible material connected to the fastening member near the upstream end thereof and extending radially outward therefrom; and
An expansion member that is connected to the edge and that is structurally independent of the fixed frame and comprises an elastic support structure;
The prosthetic heart valve device, wherein the expansion member is deformable in a radial direction without substantially deforming the anchoring member.
87. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the anchoring member of the prosthesis remains at least partially folded; Unfolding,
Moving the prosthesis to cause deflection of the indicator portion of the expansion member by engagement with a wall of the first heart chamber surrounding the natural heart valve;
Visualizing the indicator portion of the expansion member and determining the position of the prosthesis relative to the natural annulus based on the deflection of the indicator portion;
Deploying the anchoring member of the prosthesis so that it anchors the prosthesis in place so that it expands into engagement with heart tissue downstream of the native annulus. .
88. 90. The method of embodiment 87, wherein the indicator portion comprises a radiopaque material and the indicator portion is visualized using fluoroscopy.
89. 90. The method of embodiment 87, wherein the indicator portion comprises an echogenic material and the indicator portion is visualized using ultrasound.
90. 90. The method of example 87, wherein the indicator portion comprises one or more metallic members.
91. 90. The method of embodiment 87, wherein the indicator portion is deflected about an axis that is substantially parallel to a plane containing the natural annulus.
92. 90. The method of embodiment 87, wherein the indicator portion forms an angle with a surface containing the natural annulus, and the angle increases as the indicator portion is deflected.
93. The indicator portion forms a first angle with the surface during the visualization step, and the indicator portion has a second angle less than the first angle with the surface before the anchoring member is deployed. 94. The method of embodiment 92, further comprising moving the prosthesis after the visualization step to form.
94. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the anchoring member of the prosthesis remains at least partially folded; Unfolding,
Deploying the anchoring member of the prosthesis such that it expands into engagement with heart tissue downstream of the natural annulus to anchor the prosthesis in place;
Allowing the expansion member to deform radially to a greater extent than any deformation of the anchoring member.
95. 95. The method of embodiment 94, further comprising enlarging a tubular valve support coupled to the anchor member, the valve support having a valve coupled thereto.
96. 96. The method of embodiment 95, wherein the valve support has a lower limb coupled to a downstream end of the anchoring member and an upper limb mechanically isolated from the upstream end of the anchoring member.
97. 99. The method of embodiment 96, further comprising allowing the anchoring member to deform radially without substantially deforming the second end of the valve support.
98. 95. The method of embodiment 94, wherein the expansion member is coupled to the securing member by a flexible coupling member, and the coupling member is substantially less rigid than the securing member.
99. 99. The method of example 98, wherein the connecting member is a fiber.
100. A prosthetic heart valve device,
An anchoring member having a radially expandable frame with an interior and an upstream end and a downstream end, wherein the upstream end is located at and / or downstream of the natural annulus of the heart valve in the subject An anchoring member comprising a tissue fixation portion configured to engage tissue and configured to be at least partially deformable to conform to the shape of the tissue;
A closed position that is positioned relative to the securing member and that blocks blood flow through the interior; and an open position in which blood flow through the interior is permitted in the direction of flow from the upstream end to the downstream end. A valve having at least one leaflet that is movable from the valve, when the valve is deformed so that the tissue fixation portion conforms to the shape of the tissue, the valve remains competent A valve spaced inwardly from the tissue fixation portion of the anchoring member, and
An expansion member flexibly coupled to the anchoring member proximate to the upstream end of the expandable frame, the expansion member extending longitudinally along the direction of flow in a thin configuration. And an expansion member biased to project laterally with respect to the direction of flow in the deployed configuration, and wherein the expansion member is configured to deform relative to the expandable frame in the deployed configuration. And the prosthetic heart valve device.
101. 100. The prosthetic heart valve device of example 100, wherein the expansion member comprises an edge that projects from the upstream end of the frame.
102. 100. The prosthetic heart valve device of example 100, wherein the expansion member comprises a shoulder.
103. 101. The prosthetic heart valve device of example 100, wherein the expansion member comprises an expansion ring separate from the anchoring member, and the device further comprises a tether attached to the expansion ring and the anchoring member.
104. 104. The prosthetic heart valve device of any of examples 101, 102, and 103, wherein the edge comprises a cover.
105. 105. The prosthetic heart valve device of example 104, wherein the cover comprises a web material.
106. 106. The prosthetic heart valve device of example 105, wherein the web comprises a woven, braided, and / or lattice of flexible material.
107. 107. The prosthetic heart valve device of any of Examples 105 and 106, wherein the web comprises a shape memory polymeric material, shape memory metal, and / or fibers.
108. 108. The prosthetic heart valve device according to any of examples 101-107, wherein the expansion member further comprises a support structure attached to the edge.
109. 109. The prosthetic heart valve device of example 108, wherein the support structure comprises an inflexible member that is more rigid than the edge.
110. 110. The prosthetic heart valve device of example 109, wherein the inflexible member comprises a scaffold formed from a polymeric material and / or metal.
111. 111. The prosthetic heart valve device of example 110, wherein the scaffold has a serpentine, zigzag, rhombus pattern, and / or square pattern.
112. 112. The prosthetic heart valve device of example 111, wherein the scaffold comprises continuous struts.
113. 112. The prosthetic heart valve device of example 111, wherein the scaffold comprises a plurality of struts connected together.
114. 114. The artificial heart according to any of embodiments 108-113, wherein the support member is spaced from the expandable frame such that the support member is only indirectly connected to the anchoring member by the edge. Valve device.
115. 114. The prosthetic heart valve device of Examples 108-113, wherein the support member is mechanically isolated from the expandable frame.
116. 116. The prosthetic heart valve device of example 115, wherein the support member is spaced from the frame of the anchoring member and indirectly connected to the anchoring member by the edge.
117. 114. The prosthetic heart valve device of any of embodiments 108-113, wherein the support member is directly connected to the expandable frame.
118. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the fixation member of the prosthesis remains at least partially folded; Unfolding,
Moving the prosthesis in a downstream direction so that the expanded expansion member folds inwardly at least partially and positions the fixation member in a desired location relative to the natural annulus;
Deploying the fixation member of the prosthesis to secure the prosthesis in place so that it expands into engagement with heart tissue downstream of the natural annulus. .
119. 118. The method of embodiment 118, further comprising visualizing the expansion member that folds inwardly while moving the prosthesis downstream via an imaging modality.
120. 120. The method of any of embodiments 118 and 119, wherein the expansion member aligns the securing member with the natural annulus.
121. 121. The method of any of examples 118-120, wherein the expansion member is configured for tissue ingrowth so that the expansion member provides additional fixation and sealing over time.

Conclusion The above detailed description of embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. While specific embodiments and examples of the technology are described above for purposes of illustration, various equivalent modifications are possible within the scope of the technology, as will be appreciated by those skilled in the art. For example, the steps are presented in a given order, but alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

  From the foregoing, specific embodiments of the present technology have been described herein for purposes of illustration, but are well known to avoid unnecessarily obscuring the description of the embodiments of the technology. It will be understood that the structure and function of are not shown or described in detail. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

  Also, unless the word “or” refers to a list of two or more items and is explicitly limited to mean only a single item exclusive from other items, then such a The use of “or” in a list means (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. It is to be interpreted as including. In addition, the term “comprising” includes at least the described feature (s) so that any greater number of identical features and / or other features of additional types are not excluded. Used throughout to mean. Also, although specific embodiments are described herein for purposes of illustration, it will be understood that various modifications may be made without departing from the technology. Furthermore, although the advantages associated with certain embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and all embodiments However, such advantages are not necessarily required to fall within the scope of the present technology. Accordingly, the present disclosure and related art may encompass other embodiments that are not explicitly shown or described herein.

Claims (92)

A prosthetic heart valve device for treating a natural heart valve having a natural annulus and a natural leaflet,
A valve support having an upstream region and a downstream region relative to a direction of blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve comprising a plurality of leaflets And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
An anchoring member comprising an outwardly facing securing portion arranged around the valve support and having an engagement surface configured to engage tissue at an implantation site proximate to the natural annulus, An anchoring member having a first cross-sectional shape in an unbiased condition and deformable to a second cross-sectional shape to conform to the shape of the tissue at the implantation site in an unfolded condition;
A connection structure interconnecting the fixed part to the valve support, wherein the fixed part extends from the connection structure in a transition area, the transition area being located below the natural annulus And a connection structure configured to allow the fixed portion to be deflected at an angle with respect to the connection structure,
When the anchoring member is deformed to the second cross-sectional shape, the tissue fixing portion of the anchoring member is configured to support the valve so that the upstream region of the valve support maintains the undeformed shape. The prosthetic heart valve device mechanically isolated from the upstream region of the body.   The prosthetic heart valve device of claim 1, further comprising a plurality of ridges extending upstream from the fixation surface.   The prosthetic heart valve device of claim 1, wherein the fixation portion is biased radially outward to apply a compressive force to natural tissue at the implantation site.   In an unbiased condition, the connection structure extends in a direction transverse to the direction of the blood flow, and the engagement surface is arranged longitudinally at an angle different from the connection structure with respect to the direction of the blood flow The prosthetic heart valve device of claim 1, wherein:   The prosthetic heart valve device of claim 1, wherein the anchoring portion has at least one tissue engaging feature configured to engage tissue on a lower annulus of the natural annulus.   The transition area is configured to be positioned below the natural annulus, and the fixed portion is deflectable such that the engagement surface gradually decreases inward in the upstream direction. 2. The prosthetic heart valve device according to 1.   The prosthetic heart valve device according to claim 1, wherein the connection structure comprises a plurality of struts, each strut having an inner end connected to the valve support and an outer end connected to the anchoring member. .   The prosthetic heart valve device of claim 1, wherein the fixation portion and the connection structure comprise metal struts, and the transition area comprises a bend in the metal strut from the connection structure to the fixation portion.   The prosthetic heart valve according to claim 1, wherein the fixation portion is attached to the connection structure by a fastener configured to pivot, rotate, or flex in an inward and / or outward orientation. .   The prosthetic heart valve device according to claim 1, wherein the connection structure has a flared portion extending outward in the upstream direction.   When the fixing member is at the embedding site, the flared portion of the connection structure is arranged in the downstream direction from the fixed portion so that the connection structure is entirely disposed downstream of the natural annulus. The prosthetic heart valve of claim 10 extending in an orientation.   The connection structure has an upstream end connected to the anchoring member, the upstream end configured to be positioned at or below the natural annulus when the anchoring member is at the implantation site. 11. The prosthetic heart valve device of claim 10, wherein:   The prosthetic heart valve device of claim 1, wherein the connection structure comprises a flexible web that couples the fixed portion to the valve support.   The prosthetic heart valve device of claim 13, wherein the flexible web comprises a first portion at the upstream end of the valve support and a second portion at the downstream end of the valve support.   The prosthetic heart valve device of claim 1, wherein the engagement surface is deflectable over various angles with respect to the connection structure. The fixed portion comprises a skirt covering its inward surface;
The valve support includes a tubular valve cover extending around the valve support;
The prosthetic heart valve device of claim 1, wherein the skirt is attached to the valve cover to prevent blood flow between the skirt and the valve cover.   The prosthetic heart valve device of claim 1, wherein the fixation surface extends in a direction at least substantially parallel to a longitudinal axis of the anchoring member.   The prosthetic heart valve device of claim 1, wherein the transition zone is configured to be positioned below the natural annulus. A prosthetic heart valve device for treating a natural heart valve having a natural annulus and a natural leaflet,
A valve support having an upstream region and a downstream region relative to a direction of blood flow through a natural heart valve of a human heart, wherein the upstream region is configured to support a prosthetic valve, the prosthetic valve comprising a plurality of leaflets And a valve support having an undeformed shape, wherein the leaflets are sufficiently joined to prevent backflow through the prosthetic valve;
An adhering member arranged around the circumference of the valve support and including a connection structure and a fixed part, wherein the connection structure has an inner end connected to the valve support and an outer end connected to the fixed part. An intermediate portion extending outwardly from the valve support in a direction transverse to the direction of blood flow between the inner end and the outer end, and the fixed portion of the natural heart valve An outwardly engaging surface configured to engage tissue at an implantation site above or below a natural annulus, wherein the engaging surface is in a longitudinal direction different from a transverse direction of the connecting structure Extending and having the first cross-sectional shape in an unbiased condition and deformable to a second cross-sectional shape to match the shape of the tissue at the implantation site in the deployed state A fixing member;
When the fixing member is deformed to the second cross-sectional shape, the fixing portion of the fixing member is the valve support so that the upstream region of the valve support maintains the undeformed shape. The prosthetic heart valve device mechanically isolated from the upstream region of the device.   20. The prosthetic heart valve device of claim 19, wherein the connection structure comprises a web extending between the valve support and the fixed portion. The securing portion includes a first frame having a metal post defining an inner surface and the outward engagement surface; and a skirt covering the inner surface of the frame;
The valve support comprises a cylindrical second frame having a metal post; and a valve cover extending around the valve support;
20. The prosthetic heart valve device of claim 19, wherein the connection structure comprises a metal post that extends laterally from the valve support to the fixed portion.   The intermediate portion of the connection structure extending outwardly from the valve support is configured to be disposed generally downstream of the natural annulus when the anchoring member is at the implantation site; 20. The prosthetic heart valve device of claim 19.   20. The artificial heart of claim 19, wherein the outer end of the connection structure is an upstream end configured to be positioned below the natural annulus when the anchoring member is at the implantation site. Valve device.   20. The prosthetic heart valve device of claim 19, wherein the anchoring member is configured to protect the prosthetic heart valve device in the natural annulus from forces during ventricular systole.   The anchoring member further comprises a tissue engaging element protruding from the anchoring portion, wherein an upstream force on the prosthetic heart valve device during ventricular systole results in an upward force on the natural annulus, and the anchoring portion The anchoring member against the tissue on the downstream surface of the natural annulus such that it is resisted by a combination of frictional force between the natural annulus and the engagement of the tissue engaging element with natural tissue. 20. The prosthetic heart valve device of claim 19, configured to engage.   20. The prosthetic heart valve device of claim 19, wherein the longitudinal direction in which the outward engaging surface extends is parallel to the longitudinal axis of the anchoring member.   20. The prosthetic heart valve device of claim 19, wherein the outwardly engaging surface tapers inwardly in an upstream direction.   20. The prosthetic heart valve device of claim 19, wherein the connection structure comprises a plurality of struts, each strut having an inner end connected to the valve support and an outer end connected to the anchoring member. .   20. The prosthetic heart valve device of claim 19, wherein the outwardly engaging surface is deflectable over various angles with respect to the connecting structure.   The fixed portion comprises a skirt covering its inward surface, and the valve support includes a tubular valve cover extending around the valve support, the blood flow between the skirt and the valve cover 20. The prosthetic heart valve device of claim 19, wherein the skirt is attached to the valve cover to prevent A prosthetic heart valve device,
An anchoring member having a tubular securing frame with an inlet end and an outlet end;
A first portion coupled to the anchoring member and a second portion mechanically isolated from the anchoring member, whereby the inlet end of the anchoring member substantially occupies the second portion. A tubular valve support that is radially deformable without mechanical deformation;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support and an open position allowing blood flow downstream through the valve support. A valve having one leaflet;
An expansion member coupled to the stationary frame and extending radially outward therefrom, wherein at least a deformable portion of the expansion member is mechanically isolated from the anchoring member, thereby The prosthetic heart valve device comprising: an expansion member, wherein the deformable portion is radially deformable without substantially deforming the anchoring member.   The support member includes an edge formed of a sheet of flexible material coupled to the fixed frame and extending radially outward therefrom; and a support structure coupled to the edge. 32. The prosthetic heart valve device of claim 31, wherein the structure is more rigid than the edge. A prosthetic heart valve device,
A fixing member having a connection structure and a radially expandable fixed frame, wherein the connection structure is connected to the fixed frame, and a second end is connected to the valve support. And a fixing member having a side portion separating the fixed frame from the valve support,
Connected to the valve support and movable from a closed position where blood flow through the interior is blocked and an open position where blood flow through the interior is allowed in the direction of flow from the inlet end to the outlet end. A valve having at least one leaflet;
An expansion member,
An edge composed of a sheet of flexible material connected to the fixed frame and extending radially outward therefrom; and a support structure connected to the edge, the support structure being the edge An expansion member that is more rigid than
The expansion member is deflectable relative to the fixed frame around an axis transverse to the direction of flow, so that the fixed frame is deformed at least partially independently from the valve support. The prosthetic heart valve device configured.   63. The prosthetic heart valve device according to any of claims 61 and 62, wherein the support structure is elastic and more flexible than the fixed frame.   35. The artificial heart according to any of claims 31 to 34, wherein the valve support comprises a generally cylindrical valve frame formed around a longitudinal axis extending between the inlet end and the outlet end. Valve device.   36. The prosthetic heart valve device of claim 35, wherein the valve frame has an upper limb and a lower limb, and the anchoring member is coupled to the lower limb of the valve frame.   37. The prosthetic heart valve device of claim 36, further comprising a plurality of connecting members interconnecting the lower limb of the valve frame and the anchoring member.   Radially from the upper limb of the valve frame such that the upstream end of the anchoring member is deformable in the radial direction without substantially deforming the upper limb of the valve frame. 38. The prosthetic heart valve device of claim 36, which is spaced apart.   35. The prosthetic heart valve device according to any of claims 32-34, wherein the anchoring member comprises a cover of flexible material coupled to and surrounding the fixed frame.   40. The prosthetic heart valve device of claim 39, wherein the edge has an inner edge attached to the circumference of the cover.   40. The prosthetic heart valve device of claim 39, wherein the edge and the cover comprise a continuous sheet of material.   34. The prosthetic heart valve device according to any of claims 32 and 33, wherein the support structure comprises a plurality of struts.   43. The prosthetic heart valve device of claim 42, wherein the strut is not directly connected to the fixed frame.   43. The prosthetic heart valve device of claim 42, wherein the strut is spaced from the fixed frame.   43. The prosthetic heart valve device of claim 42, wherein the strut is directly coupled to the fixed frame.   The expansion member has a biased configuration in which it extends radially outward from the anchoring member and is deflectable to a deflection configuration in which it extends further in the upstream direction, the expansion member being 34. The prosthetic heart valve of any of claims 31-33, resiliently biased back to a configuration.   43. The prosthetic heart valve device of claim 42, wherein the struts extend radially away from the fixed frame.   43. The prosthetic heart valve device of claim 42, wherein the struts form a continuous ring around an expansion member.   49. The prosthetic heart valve device of claim 48, wherein the struts form a wavy, zigzag, or diamond pattern around the expansion member.   43. The prosthetic heart valve device of claim 42, wherein the strut is sewn to the edge.   35. The prosthetic heart valve device according to any of claims 31 to 34, wherein the expansion member comprises a plurality of discrete petals extending from an upstream end of the anchoring member.   In the deployed state, the fixation frame is configured to engage tissue downstream of the natural annulus of the heart valve and the expansion member is configured to engage tissue upstream of the natural annulus. The prosthetic heart valve device according to any of claims 31 to 34.   53. The prosthetic heart of claim 52, wherein the expansion member is configured to align the heart valve device relative to the natural annulus by engaging the tissue upstream of the natural annulus. Valve device.   35. The prosthetic heart valve device according to any of claims 32-34, wherein the support structure comprises an elastic metal or polymer mesh.   The artificial structure according to any one of claims 32 to 34, wherein the support structure is coupled to the fixed frame by a plurality of flexible connection members, and the connection member is substantially less rigid than the fixed frame. Heart valve device.   35. The prosthetic heart valve device according to any of claims 32-34, wherein the expansion member is connected to the anchoring member only by the edge. A prosthetic heart valve device,
An anchoring member having a tubular securing frame with an interior and an upstream end and a downstream end;
Moving from a closed position where the blood flow through the interior is blocked, and an open position where the blood flow through the interior is allowed in the direction of the flow from the upstream end to the downstream end. A valve having at least one leaflet that is possible;
An expansion member,
An edge made of a sheet of flexible material connected to the fastening member near the upstream end thereof and extending radially outward therefrom; and connected to the edge and constructed from the fixed frame An independently extending elastic support structure, and an expansion member.
The prosthetic heart valve device, wherein the expansion member is deformable in a radial direction without substantially deforming the anchoring member. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the anchoring member of the prosthesis remains at least partially folded; Unfolding,
Moving the prosthesis to cause deflection of the indicator portion of the expansion member by engagement with a wall of the first heart chamber surrounding the natural heart valve;
Visualizing the indicator portion of the expansion member and determining the position of the prosthesis relative to the natural annulus based on the deflection of the indicator portion;
Deploying the anchoring member of the prosthesis so that it anchors the prosthesis in place so that it expands into engagement with heart tissue downstream of the native annulus. .   59. The method of claim 58, wherein the indicator portion comprises a radiopaque material and the indicator portion is visualized using fluoroscopy.   59. The method of claim 58, wherein the indicator portion comprises an echogenic material and the indicator portion is visualized using ultrasound.   59. The method of claim 58, wherein the indicator portion comprises one or more metallic members.   59. The method of claim 58, wherein the indicator portion is deflected about an axis substantially parallel to a plane containing the natural annulus.   59. The method of claim 58, wherein the indicator portion forms an angle with a surface containing the natural annulus, and the angle increases as the indicator portion is deflected.   The indicator portion forms a first angle with the surface during the visualization step, and the indicator portion has a second angle less than the first angle with the surface before the anchoring member is deployed. 64. The method of claim 63, further comprising moving the prosthesis after the visualization step to form. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the anchoring member of the prosthesis remains at least partially folded; Unfolding,
Deploying the anchoring member of the prosthesis such that it expands into engagement with heart tissue downstream of the natural annulus to anchor the prosthesis in place;
Allowing the expansion member to deform radially to a greater extent than any deformation of the anchoring member.   66. The method of claim 65, further comprising enlarging a tubular valve support coupled to the anchor member, the valve support having a valve coupled thereto.   67. The method of claim 66, wherein the valve support has a lower limb coupled to a downstream end of the anchoring member and an upper limb mechanically isolated from the upstream end of the anchoring member.   68. The method of claim 67, further comprising allowing the anchoring member to deform radially without substantially deforming the second end of the valve support.   66. The method of claim 65, wherein the expansion member is coupled to the securing member by a flexible coupling member, the coupling member being substantially less rigid than the securing member.   70. The method of claim 69, wherein the connecting member is a fiber. A prosthetic heart valve device,
An anchoring member having a radially expandable frame with an interior and an upstream end and a downstream end, wherein the upstream end is located at and / or downstream of the natural annulus of the heart valve in the subject An anchoring member comprising a tissue fixation portion configured to engage tissue and configured to be at least partially deformable to conform to the shape of the tissue;
A closed position that is positioned relative to the securing member and that blocks blood flow through the interior; and an open position in which blood flow through the interior is permitted in the direction of flow from the upstream end to the downstream end. A valve having at least one leaflet that is movable from the valve, when the valve is deformed so that the tissue fixation portion conforms to the shape of the tissue, the valve remains competent A valve spaced inwardly from the tissue fixation portion of the anchoring member, and
An expansion member flexibly coupled to the anchoring member proximate to the upstream end of the expandable frame, the expansion member extending longitudinally along the direction of flow in a thin configuration. And an expansion member biased to project laterally with respect to the direction of flow in the deployed configuration, and wherein the expansion member is configured to deform relative to the expandable frame in the deployed configuration. And the prosthetic heart valve device.   72. The prosthetic heart valve device of claim 71, wherein the expansion member comprises an edge protruding from the upstream end of the frame.   72. The prosthetic heart valve device of claim 71, wherein the expansion member comprises a shoulder.   72. The prosthetic heart valve device of claim 71, wherein the expansion member comprises an expansion ring separate from the anchoring member, and the device further comprises a tether attached to the expansion ring and the anchoring member.   75. The prosthetic heart valve device according to any of claims 72, 73, and 74, wherein the edge comprises a cover.   76. The prosthetic heart valve device of claim 75, wherein the cover comprises a web material.   77. The prosthetic heart valve device of claim 76, wherein the web comprises a woven, braided, and / or lattice of flexible material.   78. The prosthetic heart valve device according to any of claims 76 and 77, wherein the web comprises shape memory polymer material, shape memory metal, and / or fibers.   79. The prosthetic heart valve device according to any of claims 72-78, wherein the expansion member further comprises a support structure attached to the edge.   80. The prosthetic heart valve device of claim 79, wherein the support structure comprises an inflexible member that is more rigid than the edge.   81. The prosthetic heart valve device of claim 80, wherein the inflexible member comprises a scaffold formed from a polymeric material and / or metal.   82. The prosthetic heart valve device of claim 81, wherein the scaffold has a serpentine, zigzag, rhombus pattern, and / or square pattern.   83. The prosthetic heart valve device of claim 82, wherein the scaffold comprises continuous struts.   83. The prosthetic heart valve device of claim 82, wherein the scaffold comprises a plurality of struts connected together.   85. The artificial heart according to any of claims 79 to 84, wherein the support member is spaced from the expandable frame such that the support member is only indirectly connected to the anchoring member by the edge. Valve device.   85. The prosthetic heart valve device of claim 79-84, wherein the support member is mechanically isolated from the expandable frame.   87. The prosthetic heart valve device of claim 86, wherein the support member is spaced from the frame of the anchoring member and indirectly connected to the anchoring member by the edge.   85. The prosthetic heart valve device according to any of claims 79 to 84, wherein the support member is directly connected to the expandable frame. A method for replacing a natural heart valve, comprising:
Positioning a prosthesis with a delivery device in a first heart chamber upstream of a natural annulus, wherein the prosthesis is in a folded configuration;
Expanding the prosthetic expansion member in the first heart chamber so that the expansion member expands at least partially into an expanded shape while the fixation member of the prosthesis remains at least partially folded; Unfolding,
Moving the prosthesis in a downstream direction so that the expanded expansion member folds inwardly at least partially and positions the fixation member in a desired location relative to the natural annulus;
Deploying the fixation member of the prosthesis to secure the prosthesis in place so that it expands into engagement with heart tissue downstream of the natural annulus. .   90. The method of claim 89, further comprising visualizing the expansion member that folds inwardly while moving the prosthesis downstream via an imaging modality.   91. The method of any one of claims 89 and 90, wherein the expansion member aligns the securing member with the natural annulus.   92. The method of any of claims 89-91, wherein the expansion member is configured for tissue ingrowth so that the expansion member provides additional fixation and sealing over time.

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